MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-13 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[24050794]
Further info regarding the event has been sought. A supplemental medwatch report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[24050795]
It was reported that the support arm for the ventilator broke. There was no patient involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[42201683]
(b)(4). According to information received, the support arm broke at the joint above the first bend. The support arm is by design a casting product. No parts or pictures were received back for investigation. Neither was information of how or under which circumstances the support arm broke received. Previous investigations of the support arm led to 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. It is unknown if the reported support arm was manufactured before, or after, the implementation of this change. Therefore, the cause for this event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[42201684]
(b)(4). This follow-up medwatch was created from a previously received initial medwatch with manufacturer report # : 8010042-2015-00356. The original date of the initial medwatch report was 07/24/2015. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2015-00356 |
| MDR Report Key | 5015125 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-13 |
| Date of Report | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-08-19 |
| 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 | 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 | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Manufacturer Phone | 7307705 |
| 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 | 2015-08-13 |
| Catalog Number | 6481720 |
| 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 | 2015-08-13 |