MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-05 for SAF-D-FIB 1220-002 NA manufactured by Medtronic.
[22185747]
During a cardiac arrest, while patient in pulseless ventricular tachycardia, an attempt was made to defibrillate the patient. The defibrillator pads were applied to the patient. A lifepack was used to defibrillate patient. The defibrillator discharged but there was no evidence that the shock went through to the patient. A second lifepack was then used with the same defibrillator pads. The defibrillator discharged but again there was no evidence that the shock went through to the patient. The defibrillator pads were then removed and pads manufactured by a different company were applied. The patient was then able to be defibrillated. There were no markings or burns noted at the defibrillator pad sites.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17468 |
| MDR Report Key | 17468 |
| Date Received | 1994-10-05 |
| Date of Report | 1994-06-09 |
| Date of Event | 1994-05-29 |
| Date Facility Aware | 1994-06-01 |
| Report Date | 1994-06-09 |
| Date Reported to Mfgr | 1994-06-09 |
| Date Added to Maude | 1994-11-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAF-D-FIB |
| Generic Name | DEFIBRILLATOR PAD |
| Product Code | DRK |
| Date Received | 1994-10-05 |
| Model Number | 1220-002 |
| Catalog Number | NA |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 17396 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 60 NEWARK STREET HAVERHILL MA 018321398 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1994-10-05 |