MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-04-11 for R50N RECORDER 5740068 manufactured by Draeger Medical Systems, Inc. (it/m).
[20318729]
It was reported that the customer complained that an r50n printed 1/2 of an ecg strip with a previous pt's info that was on the m300 in the header and waveform. It was further reported that the second half of the strip did contain the current pt's ecg. There was no pt injury reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20391024]
Draeger is still investigating the reported incident. A f/u report will be submitted as soon as the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220063-2012-00030 |
| MDR Report Key | 2539161 |
| Report Source | 01 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-03-16 |
| Date of Event | 2012-03-16 |
| Date Mfgr Received | 2012-03-19 |
| Date Added to Maude | 2012-09-11 |
| 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 DOLLOF |
| Manufacturer Street | 6 TECH DR. |
| Manufacturer City | ANDOVER MA 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 | R50N RECORDER |
| Generic Name | BEDSIDE RECORDER |
| Product Code | DSF |
| Date Received | 2012-04-11 |
| Model Number | 5740068 |
| Catalog Number | 5740068 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS, INC. (IT/M) |
| Manufacturer Address | 3135 QUARRY RD. TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-11 |