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TechNet E-Mail Forum <[log in to unmask]>, Hfjord <[log in to unmask]>
Date:
Wed, 28 Jun 2006 19:07:37 +0200
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You are little cynical now. I have had some cooperation with two pacemaker
companies. At least those two were far from what you describe. They tested
all components according to MIL levels, and had  very advanced incoming
inspection labs. In fact, the whole qualification process, and the many test
and inspection steps were so extensive and expensive, that the cost of the
capacitors was just a farth. The final tests were also very rigorous, e.g.
each pacemaker was burn-in'ed for 168 hs and retested. Common failures like
what you anticipate ought to be found before delivery. Instead, i think it's
about some kind of slow parameter drift. Maybe caused by increased leakage
after a year or more. Such failures are extremly hard to predict.

I know the manufacturing manager at one of these companies, known him since
years. He would never accept any purchasing arguments like the one you
mention.

Ingemar Hernefjord
Ericsson Microwave Systems


----- Original Message -----
From: "Dave Simonik" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Wednesday, June 28, 2006 5:12 PM
Subject: Re: [TN] Bad capacitors in Boston Scientific Defibrillators and
Pacema kers...


> 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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