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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 6895
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
The patient advised that he had previously broken his femur from an unrelated incident and had a plate installed on the bone.He indicated that his doctor believes that the plate may have prevented him from sustaining a full break from this fall.The patient is currently under his doctor's care, but he has not received any medical treatment at this time, as the doctor is hoping the crack will heal naturally.The underlying cause of the caster detaching is undetermined.The patient advised that he weighs about 197 pounds, which is within the chair's weight capacity of 300 pounds.The patient stated that when the fire department arrived at his home, the fire chief inspected the chair and noted that it looked like the threads were stripped on the inside of the wheel assembly.The patient indicated that he did not notice anything unusual about the chair leading up to the incident.He stated that the only recent maintenance the chair had is that someone tightened up the rear wheels.The shower commode chair owner's manual advises to inspect the front casters periodically for cracks and wear and to inspect the wheel/axle assembly weekly for proper tension.The shower chair has exceeded its expected life of 3 years.It was manufactured in may 2015, making it 4.5 years old at the time of the incident.It was requested that the shower chair be returned to invacare for inspection.Should additional information become available, a supplemental record will be filed.
 
Event Description
The dealer reported that the left front caster fell off the 6895 shower commode chair, which caused the patient to fall and crack his femur.The patient advised that the incident occurred while he was using a transfer table to transfer from his power chair into the shower chair.He stated that he was the only person in the house, so he had to call the fire department for assistance when he fell.He was taken to the emergency room and given an x-ray, which identified a crack in his femur bone.
 
Manufacturer Narrative
The shower commode chair was returned to invacare for evaluation, which was completed on 01/28/2020.It was observed that the left front caster was attached to the chair.Holes had been drilled into the frame of the chair where the caster stem is inserted, and some type of epoxy glue was holding the caster in place.This indicates that a "repair" of the device was attempted.Once the caster was loosened and removed, it was noted that the threads in the frame were stripped, which would have prevented the caster from attaching to the chair as intended.The end user was contacted to inquire about the modifications that had been made to the shower chair.He advised that he had no way to shower without the chair, so he had to fix it temporarily while waiting for the replacement chair.He indicated that since the threads were stripped, the epoxy is the only solution he found that would allow him to continue using the chair while showering.
 
Event Description
The dealer reported that the left front caster fell off the 6895 shower commode chair, which caused the patient to fall and crack his femur.The patient advised that the incident occurred while he was using a transfer table to transfer from his power chair into the shower chair.He stated that he was the only person in the house, so he had to call the fire department for assistance when he fell.He was taken to the emergency room and given an x-ray, which identified a crack in his femur bone.
 
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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 Key9458244
MDR Text Key170491968
Report Number1531186-2019-00009
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 12/12/2019,11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number6895
Device Catalogue Number6895
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA12/12/2019
Distributor Facility Aware Date11/18/2019
Device Age4 YR
Event Location Home
Date Report to Manufacturer12/12/2019
Date Manufacturer Received11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight89
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