MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-05 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[49564778]
It was reported that the support arm broke at the short arm segment. The ventilator was connected to a patient at the time. The arm broke as it was being moved by the nurse. There was no patient harm reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[55122834]
The investigation of the returned support arm has been finalized. The support arm is manufactured by casting. Visual inspection of the returned support arm breaking point was the joint closest to the bracket. Visual observation shows that of the broken cross section there is a color variation. One half is dark grey and the other lighter. This variation indicates that the breakage did not occur at the same time. The lighter grey occurred first and the dark grey being the most recent. The microscopic picture of the broken cross section shows no porosity and no indication of a casting defect. The information from the hospital stated that the short arm segment of the support arm snapped as the nurse was adjusting the ventilator tubing. The conclusion in the matter is that the support arm casting developed a crack at an earlier occasion indicated by the light grey area and later snapped when adjusting which is indicated by the dark grey section. The cause of the cracking cannot be determined but it was most probably due a mechanical impact.
Patient Sequence No: 1, Text Type: N, H10
[55122835]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2016-00318 |
| MDR Report Key | 5768853 |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-13 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2016-07-05 |
| 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 Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Manufacturer G1 | MAGNUS LINDQVIST |
| Manufacturer Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 177 |
| Generic Name | SUPPORT, ARM |
| Product Code | IOY |
| Date Received | 2016-07-05 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-05 |