Model Number M3535A |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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A follow-up report will be submitted once the investigation is completed.
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Event Description
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It was reported to philips that the device experienced a shock equipment malfunction, pacer failure, and defib test failure.There was no patient involvement.
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Event Description
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It was reported to philips that the device experienced a shock equipment malfunction, pacer failure, and defib test failure.There was no patient involvement.One therapy pca was returned for failure analysis.The reported problem could not be verified or duplicated during lab tests and there was no fault found with this therapy pca.The reported problem about defib and pacer test failure on op check was not verified or duplicated during lab tests even after running multiple op checks.The test fixture with the therapy pca under test installed powered up normally and passed all tests including pacer tests.The therapy pca will be scrapped.
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Manufacturer Narrative
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Additional info: b5 added failure analysis info.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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