FDA Adverse Event
Malfunction
Summary report: N
SUPPORT ARM 176
MDR report key: 4524235
·
Received February 11, 2015
Report
- Report Number
- 8010042-2015-00048
- Event Type
- Malfunction
- Date Received
- February 11, 2015
- Date of Event
- January 23, 2015
- Report Date
- January 23, 2015
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- IOY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PART HAS BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SUPPORT ARM HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100100 | SUPPORT ARM 176 | IOY | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |