RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received Jun 5, 2025 · Event occurred May 31, 2025
Report 1931307-2025-00016 · MDR key 22154438
Device
Generic name
Bari Rehab Platform 3 - 39"/48" X 80"
Manufacturer
Agiliti Health - HaysModel number
45060100Product problems
- No Apparent Adverse Event
- Insufficient Device Problem Information
- No Apparent Adverse Event
- Insufficient Device Problem Information
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
TESTING HAS NOT YET BEEN COMPLETED. AN UPDATED MDR WILL BE SENT UPON TESTING COMPLETION.
Description of Event or Problem
HOSPITAL REPORTED STAFF MEMBER HAD SEVERE SHOULDER INJURY FROM ATTEMPTING TO MOVE THE BED AND RECEIVED TREATMENT AT ER. HOSPITAL REPORTED BED IN WORKING CONDITION AND PROCEEDED TO PLACE INTO PATIENT USE.
Additional Manufacturer Narrative
OUT OF AN OVERABUNDANCE OF CAUTION THE TYPE OF REPORT WAS ORIGINALLY SUBMITTED AS A '5-DAY' AS WE DID NOT HAVE ALL INFORMATION AVAILABLE AT THE TIME OF THE INITIAL REPORT. IT HAS BEEN UPDATED TO '30-DAY'. TESTING OF THE BED FOUND THAT UNIT PASSED ALL TESTING WITH NO PROBLEMS FOUND.