MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-21 for SUPPORT ARM 176 6405976 manufactured by Maquet Critical Care Ab.
[3523222]
It was reported that while the attendant was treating the pt with his back to the ventilator and support arm, he felt the support arm hit his back. He subsequently found the support arm broken at the "short segment" joint but the actual break is on the long arm side. There was no reported harm. (b)(4). Ref number: 8010042-2013-00079.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008355164-2013-00128 |
| MDR Report Key | 3142309 |
| Date Received | 2013-05-21 |
| Date of Report | 2013-04-25 |
| Date of Event | 2013-04-19 |
| Date Facility Aware | 2013-05-21 |
| Report Date | 2013-05-21 |
| Date Added to Maude | 2013-06-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 074700000 |
| Manufacturer Country | US |
| Manufacturer Postal | 074700000 |
| Manufacturer G1 | MAQUET MEDICAL SYSTEMS USA |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 176 |
| Product Code | IOY |
| Date Received | 2013-05-21 |
| Model Number | NA |
| Catalog Number | 6405976 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-21 |