SUPPORT ARM 177
Received Jul 5, 2016 · Event occurred Jun 10, 2016
Report 8010042-2016-00318 · MDR key 5768853
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE AT THE SHORT ARM SEGMENT. THE VENTILATOR WAS CONNECTED TO A PATIENT AT THE TIME. THE ARM BROKE AS IT WAS BEING MOVED BY THE NURSE. THERE WAS NO PATIENT HARM REPORTED. (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION OF THE RETURNED SUPPORT ARM HAS BEEN FINALIZED. THE SUPPORT ARM IS MANUFACTURED BY CASTING. VISUAL INSPECTION OF THE RETURNED SUPPORT ARM BREAKING POINT WAS THE JOINT CLOSEST TO THE BRACKET. VISUAL OBSERVATION SHOWS THAT OF THE BROKEN CROSS SECTION THERE IS A COLOR VARIATION. ONE HALF IS DARK GREY AND THE OTHER LIGHTER. THIS VARIATION INDICATES THAT THE BREAKAGE DID NOT OCCUR AT THE SAME TIME. THE LIGHTER GREY OCCURRED FIRST AND THE DARK GREY BEING THE MOST RECENT. THE MICROSCOPIC PICTURE OF THE BROKEN CROSS SECTION SHOWS NO POROSITY AND NO INDICATION OF A CASTING DEFECT. THE INFORMATION FROM THE HOSPITAL STATED THAT THE SHORT ARM SEGMENT OF THE SUPPORT ARM SNAPPED AS THE NURSE WAS ADJUSTING THE VENTILATOR TUBING. THE CONCLUSION IN THE MATTER IS THAT THE SUPPORT ARM CASTING DEVELOPED A CRACK AT AN EARLIER OCCASION INDICATED BY THE LIGHT GREY AREA AND LATER SNAPPED WHEN ADJUSTING WHICH IS INDICATED BY THE DARK GREY SECTION. THE CAUSE OF THE CRACKING CANNOT BE DETERMINED BUT IT WAS MOST PROBABLY DUE A MECHANICAL IMPACT.
Description of Event or Problem
(B)(4).