I suggest to use in such health devices assembly, a real time electrical
tests of the caps and resistors SMT.
Its make the SMT machines slower but its 100% tested.
Its not solve failures that happened after a period of time in the field.
Best Regards
Reuven ROKAH
e mail: [log in to unmask]
Brian Ellis
<[log in to unmask]>
Sent by: TechNet To
<[log in to unmask]> [log in to unmask]
cc
29/06/2006 10:17 Subject
Re: [TN] Bad capacitors in Boston
Scientific Defibrillators and
Please respond to Pacema kers...
TechNet E-Mail
Forum
<[log in to unmask]>
; Please respond
to
Brian Ellis
<[log in to unmask]>
Having worn pacemakers (still on my second one) since 1990, I'm
naturally concerned about anything related to their reliability. The
latest statistics show that mine is needed and operational 98.9% of the
time! However, there is a component much more predictably unreliable
than the capacitors: the cables/electrodes. These are of coaxial bipolar
construction with a silicone insulation for flexibility and a thin
outside sheath of some other polymer. The insulation failed on my
ventricular cable after 5 years and the gizmo was reprogrammed to
unipolar operation. It was replaced, with the box-of-tricks, 8 years
ago. At my last checkup, a month ago, I was informed that both the
auricular (atrial) cable and the new ventricular cable are failing
(insulation resistance between the poles ~100 ohms) and both have been
put into unipolar operation. This means that detection of natural pacing
signals is attenuated, so that the gizmo has to work harder, with a
reduction of battery life. At last year's check-up, I was told the
estimated remaining life was 4+ years. At this year's, it is ~2 years.
So I have lost a year's battery life because of the cable failure. When
the gizmo is replaced, both cables will be replaced. Incidentally, the
two cables are from different manufacturers.
I'll grant you, the cables do operate under hostile conditions.
Brian
Dave Simonik wrote:
> On 6/28/06, Bill Campbell wrote:
>
> probably some buyer decided he could save $.35 on a reel of 5000....
>
> Exactly. See the article: http://www.purchasing.com/article/CA624889.html
>
> Dave Simonik
> Sanmina SCI
> Owego NY Division
>
>
> -----Original Message-----
> From: Bill Campbell [mailto:[log in to unmask]]
> Sent: Wednesday, June 28, 2006 11:05 AM
> To: [log in to unmask]
> Subject: Re: Bad capacitors in Boston Scientific Defibrillators and
> Pacemakers...
>
>
> probably some buyer decided he could save $.35 on a reel of 5000....
>
> On 6/27/06, Stadem, Richard D. <[log in to unmask]> wrote:
>> Yes. If they are used for military product, this would ordinarily be
>> covered by a GUIDEP alert.
>>
>> -----Original Message-----
>> From: TechNet [mailto:[log in to unmask]] On Behalf Of Reuven ROKAH
>> Sent: Tuesday, June 27, 2006 8:58 AM
>> To: [log in to unmask]
>> Subject: Re: [TN] Bad capacitors in Boston Scientific Defibrillators
>> and Pacemakers...
>>
>> There is another important question:
>> If it capacitor failure: the capacitor supplier should inform were and
>> to whom they were sold and to alert the customers who supposed to use
>> them.......
>>
>> Best Regards
>>
>> Reuven ROKAH
>>
>> e mail: [log in to unmask]
>>
>>
>>
>> "Tempea, Ioan"
>> <itempea@POSITRON
>> .QC.CA>
>> To
>> Sent by: TechNet [log in to unmask]
>> <[log in to unmask]>
>> cc
>>
>>
>> Subject
>> 27/06/2006 16:40 Re: [TN] Bad capacitors in Boston
>> Scientific Defibrillators and
>> Pacemakers...
>> Please respond to
>> TechNet E-Mail
>> Forum
>> <[log in to unmask]>
>> ; Please respond
>> to
>> "Tempea, Ioan"
>> <itempea@POSITRON
>> .QC.CA>
>>
>>
>>
>>
>>
>>
>> I guess there is only one question to be asked: what other sources of
>> this kind of products are there?
>>
>> Ioan
>>
>> -----Original Message-----
>> From: TechNet [mailto:[log in to unmask]]On Behalf Of Stadem, Richard D.
>> Sent: Tuesday, June 27, 2006 9:31 AM
>> To: [log in to unmask]
>> Subject: Re: [TN] Bad capacitors in Boston Scientific Defibrillators
>> and Pacemakers...
>>
>>
>> I also found the article disturbing. Some of the facts in the article
>> don't quite add up.
>>
>> They sampled a small percentage. Obviously (I hope) they chose a
>> sample size based on the number of defective assemblies they were
>> seeing that would ensure the problem caps would be detected if
>> present. I assume this was after the fact was discovered. The article
>> states that they did not find any bad caps. Was not the sample size
>> large enough, or is the problem something else? I am assuming there
>> are capacitors from the bad lot still available for inspection. All of
>> the bashing of Guidant's processes is not only unprofessional, but
>> also very suspicious. These processes are carefully monitored by
>> medical quality auditors. If the problem was in product released by
>> Guidant and still being manufactured by Boston Sci, how come they did
>> not find the problem, either?
>>
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