MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-22 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[44190713]
It was reported that the support arm broke at one of the joints. There was no patient harm reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[47938759]
Our investigation into this complaint has now been finalized. It was reported that a support arm for a ventilator broke at one of the joints. Received pictures of the broken support arm confirmed the event description. Our evaluation of the received pictures showed that 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 breakage. 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 date stamp showed that the support arm associated with this complaint had been manufactured before this change was implemented in production.
Patient Sequence No: 1, Text Type: N, H10
[47938760]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2016-00224 |
| MDR Report Key | 5597818 |
| Date Received | 2016-04-22 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-02-08 |
| Date Mfgr Received | 2016-02-19 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2016-04-22 |
| 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 | 2016-04-22 |
| 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 | 2016-04-22 |