MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for ZOLL PACEMAKER/DEFIBRILLATOR N 102-K NA manufactured by Zoll.
[17512955]
Female patient involved in a plane crash with multi system trauma, patient was code blue and on zoll monitor, after being defibrillated twice the monitor stopped working, no ekg pattern appeared on the screen and the screen remained black. The patient had iv fluids via an plum pump was being bagged by hand with a pmr 2 bag maskdevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jun-93. Service provided by: independent service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: mechanical problem. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6305 |
| MDR Report Key | 6305 |
| Date Received | 1993-08-16 |
| Date of Report | 1993-07-20 |
| Date of Event | 1993-07-18 |
| Date Facility Aware | 1993-07-18 |
| Report Date | 1993-07-20 |
| Date Reported to FDA | 1993-07-20 |
| Date Reported to Mfgr | 1993-07-19 |
| Date Added to Maude | 1993-08-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOLL PACEMAKER/DEFIBRILLATOR |
| Generic Name | CARDIAC MONITOR/PACEMAKER/DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1993-08-16 |
| Model Number | N 102-K |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 0177 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 01-MAY-91 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5994 |
| Manufacturer | ZOLL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-08-16 |