MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-11-04 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[20225978]
It was reported that the support arm snapped while the therapist was adjusting it to hold the pt circuit. There was no pt harm. (b)(4). Manufacturer reference #: (b)(4). Please refer mfr report # 8010042-2013-00220.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3008355164-2013-00281 |
MDR Report Key | 3466312 |
Report Source | 99 |
Date Received | 2013-11-04 |
Date of Report | 2013-10-10 |
Date of Event | 2013-10-10 |
Date Facility Aware | 2013-10-10 |
Report Date | 2013-11-04 |
Date Reported to Mfgr | 2013-10-14 |
Date Added to Maude | 2013-11-14 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Street | 45 BARBOUR POND DRIVE |
Manufacturer City | WAYNE NJ 074700000 |
Manufacturer Country | US |
Manufacturer Postal | 074700000 |
Manufacturer G1 | MAQUET MEDICAL SYSTEMS USA |
Manufacturer Street | 45 BARBOUR POND DRIVE |
Manufacturer City | WAYNE NJ 07470000 |
Manufacturer Country | US |
Manufacturer Postal Code | 07470 0000 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SUPPORT ARM 177 |
Product Code | IOY |
Date Received | 2013-11-04 |
Model Number | NA |
Catalog Number | 6481720 |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | 6 YR |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MAQUET CRITICAL CARE AB |
Manufacturer Address | SOLNA SW |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-11-04 |