MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for REOCOR D - EXTERNAL PACEMAKER 371300 manufactured by Biotronik, Inc..
[121450172]
When coming off of cardio-pulmonary bypass a pacemaker was needed to restart the patient's heart. The pacer box did not work. When turned on, it just flashed all the lights and would not pace. The nurse had to run out of the room for another box. This malfunctioning pacer box delayed patient care and extended cpb pump time. Per biomed: this device came to biomed. Notes are below, in the end, device will be sent to manufacturer: verified operation and passed all manufacture specs. I did notice that the mode turn knob is very hard to turn and i will summit a po for an exchange. As noted in the equipment concern report; "when turned on, it just flashed all the lights and wouldn't pace. Https://manuals. Biotronik. Com/wps/proxy/https/aurum. Biotronik. Com/emanuals/manual/extdev/reocor/reocord_quickguide/de/en/d? Type=manual (on pg. 4). This would indicate failed self test. As a precaution i will send out for service and an exchange due to the mode button issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7901488 |
| MDR Report Key | 7901488 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-04-12 |
| Report Date | 2018-09-05 |
| Date Reported to FDA | 2018-09-05 |
| Date Reported to Mfgr | 2018-09-24 |
| Date Added to Maude | 2018-09-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REOCOR D - EXTERNAL PACEMAKER |
| Generic Name | PULSE GENERATOR, EXTERNAL PACEMAKER, DUAL CHAMBER |
| Product Code | OVJ |
| Date Received | 2018-09-24 |
| Returned To Mfg | 2018-04-18 |
| Model Number | 371300 |
| Catalog Number | 371300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK, INC. |
| Manufacturer Address | 6024 JEAN ROAD LAKE OSWEGO OR 97035 US 97035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-24 |