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 2014-09-19 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[4919195]
It was reported that the support arm broke. There was no pt involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12372028]
No parts are available for investigation since they were scrapped by the customer. Due to this fact, the root cause of the breakage cannot be established. According to the received info, the support arm broke at the joint nearest to the bracket. No info regarding manufacturing date of the support are has been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010042-2014-00428 |
| MDR Report Key | 4122017 |
| Report Source | 05,06,07 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-08-20 |
| Date Facility Aware | 2014-08-20 |
| Report Date | 2014-09-19 |
| Date Reported to Mfgr | 2014-08-22 |
| Date Mfgr Received | 2014-08-20 |
| Date Added to Maude | 2014-10-02 |
| 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 | 2014-09-19 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-09-19 |