SUPPORT ARM 179
Received Jul 21, 2020 · Event occurred Jul 17, 2020
Report 8010042-2020-00457 · MDR key 10301814
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 179Catalog number
6882001
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Prefer Not To Disclose
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PROVIDED PICTURE SHOWED THAT THE METAL FASTENING MECHANISM ON THE RAIL CLAMP MOUNTED ON THE SUPPORT ARM HAD FALLEN OFF. THE SUPPORT ARM WILL BE REPLACED. THE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FOR PATIENT TUBING MOUNTED ON THE VENTILATOR BROKE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).
Description of Event or Problem
MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
THE SUPPORT ARM WAS RETURNED FOR INVESTIGATION. THE FIXATION PLATE ON THE RAIL CLAMP THAT IS USED FOR FIXATING THE SUPPORT ARM ON THE VENTILATOR¿S SIDE RAIL WAS MISSING AND THE FIXATION SCREW WAS BROKEN OFF. THE ROOT CAUSE OF THE BROKEN SUPPORT ARM HAS NOT BEEN CONCLUSIVELY DETERMINED BUT MOST LIKELY HAS IT BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN.