MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2015-02-11 for SUPPORT ARM 176 6405976 manufactured by Maquet Critical Care Ab.
[5411928]
It was reported that the support arm had cracks. There was no patient involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12812457]
The part has been requested back for investigation. A supplemental medwatch will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[37073680]
The broken support arm was received back for investigation, wherein visual inspection of the support arm confirmed the reported cracks. The support arm was manufactured in august of 2002. The position of the break indicates that the support arm had veen overloaded, however, the true cause for the broken support arm/ has/can not be determined from this investigation. The support arm is designed and tested according to the standard en 60601-01.
Patient Sequence No: 1, Text Type: N, H10
[37073681]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2015-00048 |
| MDR Report Key | 4524235 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-02-11 |
| Date of Report | 2015-01-23 |
| Date of Event | 2015-01-23 |
| Date Mfgr Received | 2015-01-23 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2015-03-13 |
| 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 Contact | MAGNUS LINDQVIST |
| Manufacturer Street | 2 ROENTGENVAGEN |
| Manufacturer City | SOLNA S-17154 |
| Manufacturer Country | SW |
| Manufacturer Postal | S-17154 |
| Manufacturer Phone | 7307705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 176 |
| Product Code | IOY |
| Date Received | 2015-02-11 |
| Catalog Number | 6405976 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-02-11 |