MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-24 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[29846428]
October 23, 2015 01:18 pm (gmt-4:00) added by (b)(6): evaluation of returned photographs shows 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 breaking. Previous investigations led to a redesign and a change of the manufacturing process in order to obtain a higher mechanical strength of the support arm. This change was implemented in production during september 2009. The date stamp on the reported support arm shows that it was manufactured before the implementation of this change.
Patient Sequence No: 1, Text Type: N, H10
[29846429]
It was reported that the support arm for the ventilator broke while the ventilator was connected to a patient. There was no patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2015-01045 |
| MDR Report Key | 5174047 |
| Date Received | 2015-10-24 |
| Date of Report | 2015-10-08 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-10-08 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2015-10-24 |
| 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 |
| 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 | 2015-10-24 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-24 |