MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2005-06-16 for SUPERPAC BATTERY 001647 manufactured by Mrl, Inc. A Welch Allyn Company.
[17482659]
The device worked properly for the first charge but did not charge for its second use. The customer indicated that the "battery seemed to be flat". Another battery showed the same behavior. The pt was treated successfully with another defibrillator and there was no adverse pt outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418729-2005-00082 |
| MDR Report Key | 639796 |
| Report Source | 01,07 |
| Date Received | 2005-06-16 |
| Date of Report | 2005-01-31 |
| Date Mfgr Received | 2005-01-31 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2005-10-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. HUY DOAN |
| Manufacturer Street | 1000 ASBURY DR., STE 17 |
| Manufacturer City | BUFFALO GROVE IL 600894551 |
| Manufacturer Country | US |
| Manufacturer Postal | 600894551 |
| Manufacturer Phone | 8475200300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERPAC BATTERY |
| Generic Name | DEFIBRILLATOR/ECG MONITOR |
| Product Code | DRR |
| Date Received | 2005-06-16 |
| Returned To Mfg | 2005-04-25 |
| Model Number | SUPERPAC BATTERY |
| Catalog Number | 001647 |
| Lot Number | 517138 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 629324 |
| Manufacturer | MRL, INC. A WELCH ALLYN COMPANY |
| Manufacturer Address | 1000 ASBURY DR. STE 17 BUFFALO GROVE IL 600894551 US |
| Baseline Brand Name | PIC 50 |
| Baseline Generic Name | DEFIBRILLATOR/ECG MONITOR |
| Baseline Model No | SUPERPAC BATTER |
| Baseline Catalog No | 001647 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-16 |