SHOWER CHAIR W/O BACK METAL FEET 250LB
Received May 11, 2018 · Event occurred Apr 10, 2018
Report 1423537-2018-00198 · MDR key 7506108
Device
Generic name
Adaptor, Hygiene
Manufacturer
Jan Mao Industries Co. Ltd.Model number
ZCHSBH01Catalog number
ZCHSBH01
Lot number
N/A
Product problems
- Break
- Break
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD COULD NOT BE VERIFIED AS A LOT NUMBER WAS NOT PROVIDED. REVIEW OF THE PRODUCTION PROCESS CONFIRMED THAT ALL BATCHES OF PRODUCTS WERE TESTED TO MEET STATIC LOADING OF 300 POUNDS. THE COMPLAINT DESCRIPTION INDICATED THAT THE LEGS BROKE IN HALF AND THE PATIENT FELL. THE DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. NUMEROUS ATTEMPTS WERE MADE TO OBTAIN THE DEVICE, MORE INFORMATION PERTAINING TO THE USER, CONDITION OF THE CHAIR BEFORE AND AFTER THE FAILURE AND THE EVENTS THAT LEAD TO THE FAILURE. THIS INFORMATION IS CRUCIAL TO CONFIRM THE REPORTED INCIDENT AND EVALUATE THE ROOT CAUSE FOR THE FAILURE BUT NO INFORMATION WAS PROVIDED. FROM THIS INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME, BUT WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.
Description of Event or Problem
IT WAS REPORTED THAT THE LEGS OF THE SHOWER CHAIR WITHOUT BACK BROKE IN HALF AND THE PATIENT FELL. PATIENT WAS REPORTEDLY TAKEN TO THE HOSPITAL IN AN AMBULANCE, NO DETAILS ON INJURY ARE AVAILABLE.