MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-09 for RECHARGEABLE LEAD ACID BATTERIES PRISMAFLEX FG20121; 12V 1.2AH manufactured by Gambro; Fiamm.
[1949910]
Prismaflex premature battery failure-potential for harm: four power backup batteries, have failed the biomed battery analyzer test, belong to four seperate devices. These batteries were part of the original purchased devices, we acquired less than 2 years ago. Additionally the manufacturer does not state clearly, in their maintenance instructions a required frequency to inspect the battery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2065684 |
| MDR Report Key | 2065684 |
| Date Received | 2011-04-09 |
| Date of Report | 2011-04-09 |
| Date of Event | 2011-03-07 |
| Report Date | 2011-04-09 |
| Date Reported to FDA | 2011-04-09 |
| Date Added to Maude | 2011-04-21 |
| 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 | RECHARGEABLE LEAD ACID BATTERIES |
| Generic Name | CRRT |
| Product Code | FCO |
| Date Received | 2011-04-09 |
| Returned To Mfg | 2011-03-25 |
| Model Number | PRISMAFLEX |
| Catalog Number | FG20121; 12V 1.2AH |
| Lot Number | 03089 |
| ID Number | * |
| Device Availability | R |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO; FIAMM |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Brand Name | RECHARGEABLE LEAD ACID BATTERIES |
| Generic Name | CRRT |
| Product Code | FCO |
| Date Received | 2011-04-09 |
| Returned To Mfg | 2011-03-25 |
| Model Number | PRISMAFLEX |
| Catalog Number | FG20121; 12V 1.2AH |
| Lot Number | 04089 |
| ID Number | * |
| Device Availability | R |
| Device Age | 2 YR |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO; FIAMM |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Brand Name | RECHARGEABLE LEAD ACID BATTERIES |
| Generic Name | CRRT |
| Product Code | FCO |
| Date Received | 2011-04-09 |
| Returned To Mfg | 2011-03-25 |
| Model Number | PRISMAFLEX |
| Catalog Number | FG20121; 12V 1.2AH |
| Lot Number | 04089 |
| ID Number | * |
| Device Availability | R |
| Device Age | 2 YR |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO; FIAMM |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-09 |