MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-12-13 for INFINITY R50N RECORDER 540068 manufactured by Drager Medical Systems, Inc. (it/m).
[2449948]
It was reported that during training, an infinity r50n recorder began to have a strong burning smell, smoke, and was hot to the touch after a few hours of usage. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9517144]
Draeger is still investigating the reported incident. A follow-up report will be submitted as soon as the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220063-2011-00078 |
| MDR Report Key | 2391967 |
| Report Source | 01 |
| Date Received | 2011-12-13 |
| Date of Report | 2011-11-17 |
| Date of Event | 2011-11-17 |
| Date Mfgr Received | 2011-11-17 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-07-24 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBECCA DOLLOFF |
| Manufacturer Street | 6 TECH DRIVE |
| Manufacturer City | ANDOVER MD 018102434 |
| Manufacturer Country | US |
| Manufacturer Postal | 018102434 |
| Manufacturer Phone | 9783798573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFINITY R50N RECORDER |
| Generic Name | RECORDER |
| Product Code | DSF |
| Date Received | 2011-12-13 |
| Model Number | 540068 |
| Catalog Number | 540068 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAGER MEDICAL SYSTEMS, INC. (IT/M) |
| Manufacturer Address | 3135 QUARRY ROAD TRELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-13 |