MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-07-23 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[19762548]
It was reported that the support arm broke. There was no pt involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19855491]
The broken part has been sent back for investigation. A supplemental medwatch will be provided when the investigation has been finalised. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010042-2014-00268 |
| MDR Report Key | 4080314 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-07-23 |
| Date of Report | 2014-05-26 |
| Date of Event | 2014-05-26 |
| Date Facility Aware | 2014-06-23 |
| Report Date | 2014-06-24 |
| Date Mfgr Received | 2014-05-26 |
| Date Added to Maude | 2014-09-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DR |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 177 |
| Product Code | IOY |
| Date Received | 2014-07-23 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-07-23 |