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 2014-09-05 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[4716247]
It was reported that the support arm broke. There was no pt involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12353804]
The broken support arm was not returned for investigation. Info was received that the customer scrapped the broken support arm after the replacement. No further info regarding the event has been received. With available info, the cause to the event cannot be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010042-2014-00396 |
| MDR Report Key | 4098773 |
| Report Source | 05,06,07 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-07-08 |
| Date Facility Aware | 2014-07-08 |
| Report Date | 2014-09-05 |
| Date Reported to Mfgr | 2014-08-14 |
| Date Mfgr Received | 2014-07-08 |
| Date Added to Maude | 2014-09-24 |
| 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 |
| 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 |
| Generic Name | NONE |
| Product Code | IOY |
| Date Received | 2014-09-05 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-05 |