MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2001-11-06 for FASTPAK BATTERY 9-10424 manufactured by Medtronic Physio-control Corp..
[220539]
An engineering investigation was initiated based upon failure of a fastpak battery pak. A failure of the battery pak could result in a loss of power to a device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3015876-2001-00479 |
| MDR Report Key | 361205 |
| Report Source | 05,07 |
| Date Received | 2001-11-06 |
| Date of Report | 2001-10-19 |
| Date Mfgr Received | 2001-10-19 |
| Date Added to Maude | 2001-11-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BILL GARTHE PRODUCT ANALYST |
| Manufacturer Street | 11811 WILLOWS RD NE POST OFFICE BOX 97006 |
| Manufacturer City | REDMOND WA 980739706 |
| Manufacturer Country | US |
| Manufacturer Postal | 980739706 |
| Manufacturer Phone | 4258674000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FASTPAK BATTERY |
| Generic Name | EXTERNAL DEFIBRILLATOR RECHARGEABLE BATTERY |
| Product Code | MOY |
| Date Received | 2001-11-06 |
| Model Number | NA |
| Catalog Number | 9-10424 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 350359 |
| Manufacturer | MEDTRONIC PHYSIO-CONTROL CORP. |
| Manufacturer Address | 11811 WILLOWS RD NE POST OFFICE BOX 97006 REDMOND WA 980739706 US |
| Baseline Brand Name | PASTPAK BATTERY PAK |
| Baseline Generic Name | EXTERNAL DEFIBRILLATOR RECHARGEABLE BATTERY |
| Baseline Model No | NA |
| Baseline Catalog No | 9-10424 |
| Baseline ID | NA |
| Baseline Device Family | FP BATTERY |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K890079 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-11-06 |