SUPPORT ARM 178
Received Oct 23, 2019 · Event occurred Oct 8, 2019
Report 8010042-2019-00777 · MDR key 9223757
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 178Catalog number
6693715
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FOR PATIENT TUBES, MOUNTED ON THE VENTILATOR, CARRIER BROKE. THERE WAS NO PATIENT HARM. (B)(4).
Additional Manufacturer Narrative
THE SUPPORT ARM WAS NOT RETURNED FOR INVESTIGATION. ACCORDING TO PROVIDED PICTURES AND ADDITIONAL INFORMATION, THE BALL BEARINGS ON THE RAIL CLAMP MOUNTED ON THE SUPPORT ARM WERE STUCK. THIS HAS MOST LIKELY CONTRIBUTED TO AN INABILITY TO FASTEN THE SUPPORT ARM ON THE SIDE RAIL MOUNTED ON THE VENTILATOR CARRIER. THE ROOT CAUSE OF THE STUCK BALL BEARINGS HAS NOT BEEN DETERMINED.
Description of Event or Problem
MANUFACTURER'S REF # (B)(4).