MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-09-24 for SUPPORT ARM 177 manufactured by Maquet Critical Care Ab.
[3790172]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11139116]
A supplemental medwatch will be provided when the investigation has been finalized. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010042-2013-00160 |
| MDR Report Key | 3420643 |
| Report Source | 05,06,07 |
| Date Received | 2013-09-24 |
| Date Mfgr Received | 2013-08-29 |
| Date Added to Maude | 2013-10-22 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET CRITICAL CARE AB |
| Manufacturer City | SOLNA S-17154 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | S-17154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 177 |
| Product Code | IOY |
| Date Received | 2013-09-24 |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-24 |