MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-18 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[41032779]
(b)(6) 2016 09:00 am (gmt-4:00) added by (b)(6) ((b)(4)): it was reported that the support arm for the ventilator broke. There was no patient involvement reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[47951623]
Our investigation into this complaint has now been finalized. No parts or pictures were returned for our investigation. Additional information received clarified that the support arm will not remain in its intended/desired position. Our conclusion is, that the friction in the joint has been reduced, most likely due to wear. There was/is no evidence to support a mechanical break of the device. There are service kits available for exchanging parts of the joints when they become worn out.
Patient Sequence No: 1, Text Type: N, H10
[47951624]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2016-00152 |
| MDR Report Key | 5510245 |
| Date Received | 2016-03-18 |
| Date of Report | 2016-02-25 |
| Date Mfgr Received | 2016-02-25 |
| Date Added to Maude | 2016-03-18 |
| 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 | 2016-03-18 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-03-18 |