MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-23 for DUAL CHAMBER TEMPORARY PACEMAKER 5392 manufactured by Plexus Manufacturing Sdn. Bhd.
[184637830]
Product analysis: analysis was able to confirm the customer comment that the external pulse generator (epg) displayed an error message which was found to have occurred multiple times. It was further noted during analysis that the main printed circuit board (pcb), upper case, keyboard flex, encoder knob, lower case, display, display frame, four display grommets, insulator label and two main pcb screws were contaminated. It was further noted that the hanger assembly was broken. All found defective parts were replaced and all other identified issues were resolved with firmware updated and the epg passed all final functional tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184637831]
It was reported that the external pulse generator (epg) displayed an error message. The epg was received into service and repair. No patient complications have been reported as a result of this event. It was further reported that the epg subsequently failed functional testing during manufacturer's analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004593495-2020-00310 |
| MDR Report Key | 9869179 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-12-22 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | PLEXUS MANUFACTURING SDN. BHD |
| Manufacturer Street | BAYAN LEPAS FREE INDUSTRIAL ZO |
| Manufacturer City | BAYAN LEPAS 11900 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 11900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUAL CHAMBER TEMPORARY PACEMAKER |
| Generic Name | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
| Product Code | DTE |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-02-24 |
| Model Number | 5392 |
| Catalog Number | 5392 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLEXUS MANUFACTURING SDN. BHD |
| Manufacturer Address | BAYAN LEPAS FREE INDUSTRIAL ZO BAYAN LEPAS 11900 MY 11900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |