MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-10-13 for SANYO KR-5000DEL 091121-4 manufactured by Sanyo.
[21017314]
The extracorporeal membrane oxygenation (ecmo) machine was unplugged for routine repositioning. The pump failed to operate on battery and flow was altered. The pts blood pressure and heart decreased, as well as seizure activity being noted. After approx 3 mins flow was re-established and the pt returned to baseline. The battery was tested by the biomedical engineering lab and charged overnight. It was then tested and the device was put back into service. The battery had inadvertently been unplugged while not in use, therefore it was unable to charge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2323530 |
| MDR Report Key | 2323530 |
| Report Source | 99 |
| Date Received | 2011-10-13 |
| Date of Report | 2011-08-16 |
| Date of Event | 2011-07-03 |
| Date Facility Aware | 2011-07-03 |
| Report Date | 2011-08-16 |
| Date Reported to FDA | 2011-08-16 |
| Date Added to Maude | 2011-11-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANYO |
| Generic Name | RECHARGEABLE LITHIUM BATTERY |
| Product Code | MOY |
| Date Received | 2011-10-13 |
| Model Number | KR-5000DEL |
| Catalog Number | 091121-4 |
| Lot Number | 702755 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2011-10-13 |