ALLEN INTUBATION PLATE AND PAD
Received Apr 27, 2022 · Event occurred Mar 28, 2022
Report 3010216206-2022-00002 · MDR key 14218397
Device
Product problems
- No Apparent Adverse Event
- Insufficient Device Problem Information
- No Apparent Adverse Event
- Insufficient Device Problem Information
Patient
29 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN INTUBATED PATIENT THE HYDRAULICS COMPONENT OF A BEACH CHAIR SHOULDER POSITIONER BROKE LEADING TO A ONE HOUR DELAY IN THE PROCEDURE. THERE WAS NO PATIENT OR CAREGIVER INJURY FROM THIS ALLEGED INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Additional Manufacturer Narrative
PRELIMINARY INVESTIGATION REPORTED THAT INSTABILITY OF THE DEVICE WAS OBSERVED WHEN THEY SAT THE PATIENT UP. THE SURGEON AND TEAM OPTED TO USED A CRUTCH TO SUPPORT THE DEVICE FOR THE DURATION OF THE CASE. THERE WAS NO HARM REPORTED TO THE PATIENT DUE TO THIS DELAY. THE CUSTOMER HAS RECEIVED A REPLACEMENT DEVICE. THE DEVICE INVOLVED IN THIS EVENT IS BEING RETURNED TO THE MANUFACTURER. INVESTIGATION IS ONGOING. HILLROM WILL GATHER ADDITIONAL INFORMATION ON THE CIRCUMSTANCES THAT LEAD TO THE EVENT. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.
Additional Manufacturer Narrative
THE BEACH CHAIR SHOULDER POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD AND TORSO IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO ORTHOPEDIC SURGERIES LIKE, ROTATOR CUFF, TOTAL SHOULDER, REVERSE TOTAL SHOULDER, SLAP REPAIR AND OTHER SHOULDER SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. EVALUATION OF THE DEVICE SHOWED THAT THERE WAS NO PROBLEMS WITH THE HYDRAULICS. THE GAS SPRING HYDRAULIC WAS FUNCTIONING AS DESIGNED AND PASSED I-PAC TESTING. NOTHING WAS DETERMINED TO BE WRONG WITH THE DEVICE. NO MALFUNCTION. DURING THE EVALUATION THE SERVICE AND REPAIR TECHNICIANS IDENTIFIED THAT THE WIDTH ADJUSTER ASSEMBLY WAS MISSING THE LATERAL SLIDE STOP (C-005621) (AND SCREW (C-005741)). CUSTOMERS TYPICALLY REMOVE THIS WHEN SENDING THE DEVICE BACK IN TO REPAIR TO ALLOW THE DEVICE TO MORE EASILY FIT INSIDE A SHIPPING BOX. BASED ON THIS INFORMATION, HILLROM DOES NOT CONSIDER THIS COMPLAINT REPORTABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN INTUBATED PATIENT THE HYDRAULICS COMPONENT OF A BEACH CHAIR SHOULDER POSITIONER BROKE LEADING TO A ONE HOUR DELAY IN THE PROCEDURE. THERE WAS NO PATIENT OR CAREGIVER INJURY FROM THIS ALLEGED INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).