MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-04-18 for INFINITY TRIDENT NMT POD 787610 manufactured by Draeger Medical Systems, Inc..
[3290539]
It was reported that the tof reading do not go along with the pt state. They fluctuate between oa nd 130% (ratio)/0 and 4 (amount). A new accelerometer was tried without success. There was no pt injury reported. Draeger reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10691342]
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 | 1220063-2013-00021 |
| MDR Report Key | 3089940 |
| Report Source | 01 |
| Date Received | 2013-04-18 |
| Date of Report | 2013-03-26 |
| Date of Event | 2013-03-26 |
| Date Mfgr Received | 2013-04-02 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2013-06-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBECCA DOLLOFF |
| 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 | INFINITY TRIDENT NMT POD |
| Generic Name | POD |
| Product Code | KOI |
| Date Received | 2013-04-18 |
| Model Number | 787610 |
| Catalog Number | 787610 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3135 QUARRY ROAD TELFORD MA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-18 |