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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT VERANDA 16 IN X 16 IN FRAME W/DESK LNGTH RMOV ARMS AND ELEV FTRST 9153651935; WHEELCHAIR, MECHANICAL
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JUMAO HEALTHCARE EQUIPMENT VERANDA 16 IN X 16 IN FRAME W/DESK LNGTH RMOV ARMS AND ELEV FTRST 9153651935; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number V16RFR
Device Problems Break (1069); Device Tipped Over (2589)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Type  Injury  
Event Description
The maintenance director at the facility that the end user lives called and stated that the fork stem bearings on the right fork have disintegrated.The caller states that the end user is the second user of this chair.The caller also states that when the bearings disintegrated and fell out, the fork fell off and the chair tipped over with the end user in the chair and she fell and fractured her right shoulder.The caller stated that the end user received xrays, but he was not sure they did it in house or took her to the hospital.The facilities administrator provided end user information.The facilities administrator stated they were cited by the state for a deficiency due to this incident and needs to check with the facilities operations to see how long they need to keep the chair in house.
 
Manufacturer Narrative
Updated information was added to reflect the veranda wheelchair being returned to invacare for evaluation.The following fields were updated accordingly.The v16rfr verande wheelchair was returned for evaluation, and subsequent testing verified the complaint.Per the evaluation the visual observations indicated that the right caster headtube bearings were missing and the caster was detached.Fragments of a bearing was present on the caster stem bolt.The left caster stem bolt nut was loose and the caster wheel spokes were broken.The left wheel lock was twisted on the frame.The wheelchairs left step tube step pedal was missing and there was corrosion inside the step tube.The rear wheels had hair wrapped around the bearings.Functional testing indicted that the wheelchair was difficult to fold and unfold due to foreign substances.The right removable armrest was hard to remove due to food remnants in the sockets.The left wheel lock would not stop the left rear wheel from rotating when actuated due to loose hardware.No further testing could be performed due to the severity of damage to the casters.Conclusion: in its "as received" condition, the complaint was confirmed for the right caster headtube bearings disintegrated and the right caster separated from the headtube.The serial number, (b)(4), indicates that the wheelchair is 4 years 5 months in age.The veranda wheelchair was in overall poor condition.Absence of or inadequate maintenance practices were the probable cause of the failure.Loose hardware and lack of product care likely allowed the right caster headtube bearings to become dislodged and crumble.This condition permitted the right caster to fall out.
 
Event Description
The maintenance director at the facility that the end user lives called and stated that the fork stem bearings on the right fork have disintegrated.The caller states that the end user is the second user of this chair.The caller also states that when the bearings disintegrated and fell out, the fork fell off and the chair tipped over with the end user in the chair and she fell and fractured her right shoulder.The caller stated that the end user received xrays, but he was not sure they did it in house or took her to the hospital.The facilities administrator provided end user information.The facilities administrator stated they were cited by the state for a deficiency due to this incident and needs to check with the facilities operations to see how long they need to keep the chair in house.
 
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Brand Name
VERANDA 16 IN X 16 IN FRAME W/DESK LNGTH RMOV ARMS AND ELEV FTRST 9153651935
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
JUMAO HEALTHCARE EQUIPMENT
jiashan
CH 
MDR Report Key6051663
MDR Text Key58199422
Report Number1531186-2016-00023
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 10/24/2016,01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberV16RFR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/24/2016
Distributor Facility Aware Date10/05/2016
Device Age30 MO
Event Location Nursing Home
Date Report to Manufacturer10/24/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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