MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[63191444]
It was reported that the support arm was replaced. No patient involvement reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[63729579]
While requesting further information about the support arm it was concluded that there was no fault with the support arm. The customer had request to add a support arm to the ventilator since the ventilator not was equipped with a support arm. There was no product malfunction and therefore no investigation is performed.
Patient Sequence No: 1, Text Type: N, H10
[63729580]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2016-00576 |
| MDR Report Key | 6185735 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-11-21 |
| Date Mfgr Received | 2016-11-21 |
| Date Added to Maude | 2016-12-19 |
| 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 | 3 |
| Brand Name | SUPPORT ARM 177 |
| Generic Name | SUPPORT, ARM |
| Product Code | IOY |
| Date Received | 2016-12-19 |
| 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 | 2016-12-19 |