MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for DUAL CHAMBER TEMPORARY PACEMAKER 5392 manufactured by Plexus Manufacturing Sdn. Bhd.
[184996678]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184996679]
It was reported that the bottom display cuts off and the keys lock up when a battery is placed in the external pulse generator (epg). The product has not been received into service. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[187305820]
Product analysis: analysis confirmed the customer comment as the external pulse generator (epg) lower display would cut out after start up. It was noted that the main printed circuit board (pcb) was contaminated and corroded. The upper-and lower-case halves, keypad, encoder assembly, two control knobs, main seal, tube, tube sleeve, liquid crystal display assembly, display frame, all four display frame screws, all four encoder nuts, all six case screws, the hanger screw and all six pcb screws were also noted to be contaminated. The hanger was cracked. All found defective parts were replaced and all other identified issues were resolved. The device 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
[187305821]
It was further reported that after turning on, the bottom screen stayed on only for a few seconds, then the device froze. Removing the battery did not power off the device. The epg was returned for service
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004593495-2020-00331 |
| MDR Report Key | 9881061 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2020-03-25 |
| Model Number | 5392 |
| Catalog Number | 5392 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-25 |