MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-24 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[81001241]
The facility had discarded the support arm therefore the point of break was not verified. No investigation has been possible and the true cause of breakage of the support arm has not been determined.
Patient Sequence No: 1, Text Type: N, H10
[81001242]
While a field service engineer (fse) was on site on another issue, the facility staff also informed the fse that a support arm had broken. There was no patient involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2017-00343 |
| MDR Report Key | 6735764 |
| Date Received | 2017-07-24 |
| Date of Report | 2017-10-23 |
| Date Mfgr Received | 2017-07-06 |
| Date Added to Maude | 2017-07-24 |
| 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 |
| 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 | 2017-07-24 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | YR |
| 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 | 2017-07-24 |