MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-14 for * 5503 manufactured by R & D Batteries, Inc..
[17472433]
The monitor caught fire. There was no patient in the room at the time of the event. Unit was opened and determined that the source was the battery. The battery had just been changed/replaced on 7/12/2010 and had a date code of 6/29/2010. Manufacturer response for battery, physiological monitor, (b) (6) and monitor, physiological, propaq cs: i have been in communication with a r & d batteries representative. Here is their response "in our evaluation we found the power supply to the unit failed and one of our batteries in the pack was overcharged by this failure. It is our determination that there was a failure in the charging circuit of the instrument. One of the batteries in the unit is still functional, since this is attached to the other battery through the circuit board, and the damaged battery is only connected through the connector that is interfaced with the device, it is our conclusion that an outside influence (over charge) from the device caused this failure. "the battery has a fuse (part of the battery pack) on an interface board and it is hard to believe that this device did not fail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1966153 |
| MDR Report Key | 1966153 |
| Date Received | 2011-01-14 |
| Date of Report | 2011-01-14 |
| Date of Event | 2010-08-22 |
| Report Date | 2011-01-14 |
| Date Reported to FDA | 2011-01-14 |
| Date Added to Maude | 2011-01-21 |
| 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 |
| 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 | * |
| Generic Name | BATTERY, PHYSIOLOGICAL MONITOR |
| Product Code | FCO |
| Date Received | 2011-01-14 |
| Returned To Mfg | 2010-09-02 |
| Model Number | 5503 |
| Catalog Number | 5503 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | R & D BATTERIES, INC. |
| Manufacturer Address | 3300 CORPORATE CENTER DRIVE BURNSVILLE MN 55306 US 55306 |
| Brand Name | PROPAQ CS |
| Generic Name | MONITOR, PHYSIOLOGICAL |
| Product Code | MHX |
| Date Received | 2011-01-14 |
| Model Number | 242 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 3 YR |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN PROTOCOL, INC. |
| Manufacturer Address | 8500 S.W. CREEKSIDE PLACE BEAVERTON OR 97008 US 97008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-14 |