MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-06 for SUPPORT ARM 177 61481720 manufactured by Maquet Critical Care Ab.
[104745861]
No parts were returned. The broken support arm was discarded by the user facility. Investigation was based on picture received. According to the picture, the support arm broke at the joint nearest to the bracket. The support arm is a casting and it most probably developed a crack at an earlier occasion either by overloading or impact and this led to the reported breaking. The support arm has been successfully tested for mechanical strength and is designed according to standard. It is unknown under which circumstances the support arm broke. Previous investigations of similar faults led to a redesign and change of the manufacturing process in order to obtain a higher mechanical strength of the support arm. The support arm associated with this complaint had been manufactured before this change was implemented in production. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[104745862]
It was reported that the support arm broke at the lower end. There was no patient involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2018-00176 |
| MDR Report Key | 7403153 |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-06 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-04-06 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 0 |
| Brand Name | SUPPORT ARM 177 |
| Generic Name | SUPPORT, ARM |
| Product Code | IOY |
| Date Received | 2018-04-06 |
| Catalog Number | 61481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-06 |