MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-25 for INTELLIVUE TRX+ M4841A manufactured by Philips.
[90186643]
Patient Sequence No: 1, Text Type: N, H10
[90186644]
On [date redacted], after placing the batteries in a telemetry box, the box got extremely hot. Upon opening the box and removing the batteries, the team member's fingers were slightly burned after coming in contact with the batteries. The covering of the batteries had separated. These batteries were replaced with new batteries and the box/batteries again began to heat up. It was again noted that the plastic covering of the batteries had split. The telemetry box was removed from circulation and sent to the biomedical department. The team member's slightly burned fingers were treated with bacitracin. No harm to the patient. One month later, a team member reported that the patient's telemetry box was found to be beeping and discovered that the telemetry box was hot to the touch. The team member picked up and then dropped the box (resulting in an area of redness on her hand). The team member opened the battery compartment and noted that the plastic covering on the battery was split and the battery was extremely hot. The battery was removed with folded washcloth. There was no injury to the patient as the tele box was on the patient's bed and not in the usual location (in pocket of gown). The telemetry box and batteries were pulled from service and sent to biomedical engineering to be inspected. Following-up for first event: biomed reported the case of the box was damaged and the battery conductor wires were shorted due to case damage. Telemetry box sent to manufacturer. The batteries that were separated were procells by duracell pc1500. Follow-up to 2nd event: biomed reported the case of the box was not damaged, cracked, etc. The box is an s03 case (thicker style and manufacture date 06/2016). The bus bar retainers are in place. The batteries that were split were procell by duracell pc1500.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6975915 |
| MDR Report Key | 6975915 |
| Date Received | 2017-10-25 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-08-10 |
| Report Date | 2017-09-12 |
| Date Reported to FDA | 2017-09-12 |
| Date Reported to Mfgr | 2017-09-12 |
| Date Added to Maude | 2017-10-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLIVUE TRX+ |
| Generic Name | PHYSIOLOGICAL MONITOR, CARDIOVASCULAR |
| Product Code | MSX |
| Date Received | 2017-10-25 |
| Model Number | M4841A |
| ID Number | (CASE REPLACED MAY 2016), DUR |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-25 |