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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO LTD INVACARE MARINER REHAB SHOWER CHAIR; ADAPTOR, HYGIENE
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JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO LTD INVACARE MARINER REHAB SHOWER CHAIR; ADAPTOR, HYGIENE Back to Search Results
Model Number 6795
Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Event Description
An end user reported that the right wheel lock on his 6795 shower commode chair was not working, and he ordered a replacement through his provider, but after several months he still hadn't received it.In the meantime, he continued to use the shower chair, and when he was transferring from his stair lift into the shower chair, he fell and broke his femur.He advised that he has had 3 surgeries since the incident happened, and he has a wound vac on his leg and a picc line in still.
 
Manufacturer Narrative
Based on the information provided, the event seems to have been caused because the user knowingly continued to use the chair with malfunctioning wheel locks.The rehab shower commode chair owner's manual advises that when transferring to and from other seats, be certain the wheel locks are engaged to help prevent the wheels from moving.It goes on to say, "if wheel locks do not hold the occupied rehab shower commode chair in place contact a qualified technician - otherwise injury or damage may occur." the user stated that he does not blame invacare for his injury; he faults himself for continuing to use the chair with a broken wheel lock.The underlying cause of the alleged wheel lock issue is undetermined.The end user's provider purchased wheel lock replacements from invacare in november 2021.The left wheel lock shipped, but the right wheel lock is on backorder until may.Therefore, a whole new shower chair is being sent to the end user.It has been requested that the subject shower chair be returned to invacare for evaluation.If additional information becomes available, a supplemental record will be filed.
 
Event Description
An end user reported that the right wheel lock on his 6795 shower commode chair was not working, and he ordered a replacement through his provider, but after several months he still hadn't received it.In the meantime, he continued to use the shower chair, and when he was transferring from his stair lift into the shower chair, he fell and broke his femur.He advised that he has had 3 surgeries since the incident happened, and he has a wound vac on his leg and a picc line in still.
 
Manufacturer Narrative
The shower chair was returned to invacare for evaluation.It was observed that the mounting brackets for the right wheel lock were detached from the chair, and the right wheel lock was completely missing, so the right rear wheel was unable to be locked in place.The cause of the missing wheel lock was unable to be determined.
 
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Brand Name
INVACARE MARINER REHAB SHOWER CHAIR
Type of Device
ADAPTOR, HYGIENE
Manufacturer (Section D)
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO LTD
yuyang industrial park
danyang city, jiangsu
MDR Report Key14021441
MDR Text Key288675479
Report Number1531186-2022-00002
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/06/2022,03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number6795
Device Catalogue Number6795
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA04/06/2022
Distributor Facility Aware Date03/10/2022
Device Age2 YR
Date Report to Manufacturer04/06/2022
Date Manufacturer Received03/10/2022
Date Device Manufactured01/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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