PLEXUS MANUFACTURING SDN. BHD DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL
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Model Number 5392 |
Device Problems
No Device Output (1435); Output below Specifications (3004); Unexpected Shutdown (4019)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the external pulse generator (epg) displayed an onscreen message, then shut down.It was further reported that, during user facility testing, the epg lost atrial output, when set to 1.0 millivolts (mv), and both atrial and ventricular output was lost, when set to 0.6 mv.It was noted that output tests indicated that measured current fell below the expected value of 1 milliampere.The epg was returned for service.There was no patient involvement.
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Manufacturer Narrative
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Product analysis: analysis was unable to confirm the customer comment of an onscreen message followed by a shutdown or that there was a loss of output.It was noted that the output connector assembly, hanger assembly and upper and lower cases were broken, the encoder assembly and four knobs were contaminated, the display wires were pinched with the insulation exposed and one case screw was contaminated.All found defective parts were replaced and all other identified issues were resolved.The generator then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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