MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-04 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[5163543]
It was reported tha a pt accidentally was extubated due to a self-lowering of the support arm, that holds the pt's circuit, at the level of joints. This incident lead to an emergency re-intubation, with difficult conditions. The rapid re-intubation was complicated by massive aspiration with hematosis degradation, requiring optimization of mechanical ventilation, sedation, curarization, and switching to ventral decubitus position (several sessions over 4/5 days). The final pt outcome was no injury. The support arm joints were tightened which solved the problem and the support arm was put back in use. (b)(4). Mfr ref # 8010042-2014-00549.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008355164-2014-00303 |
| MDR Report Key | 4420294 |
| Date Received | 2014-12-04 |
| Date of Report | 2014-11-07 |
| Date of Event | 2014-10-28 |
| Date Added to Maude | 2015-01-16 |
| 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 | 0 |
| 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 177 |
| Product Code | IOY |
| Date Received | 2014-12-04 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-12-04 |