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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; TRANSPORT CHAIR

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MEDLINE INDUSTRIES, INC.; TRANSPORT CHAIR Back to Search Results
Catalog Number MDS808200WX
Device Problem Use of Device Problem (1670)
Patient Problem Bone Fracture(s) (1870)
Event Date 03/23/2016
Event Type  Injury  
Manufacturer Narrative
The end user's daughter reported that while pushing on the handles to clear a curb, the left latch released and the end user fell out of the transport chair on to the ground.Her doctor diagnosed a rib fracture but it is unknown if any x-rays were done to confirm that diagnosis.The end user's daughter stated that she had tightened the release pin for the left push handle prior to this incident.The sample has been returned for evaluation.It was confirmed that an adjustment was made to the release pin for the left push handle.The release pin was not protruding enough to lock the handle into place.When adjusted correctly, the left handle securely locked into place.It is unknown if the seat belt was applied as recommended in the owner's manual.The owner's manual also states not to attempt to ride over curbs or obstacles.Doing so may cause your chair to tip over.The owner's manual further states to make sure that the seatback is locked in the upright position.We have determined that the most likely root cause for this incident to be user error.
 
Event Description
The end user's daughter reported that while pushing on the handles to clear a curb, the left latch released and the end user fell out of the transport chair on to the ground and suffered a rib fracture.
 
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Type of Device
TRANSPORT CHAIR
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
one medline place
mundelein IL 60060
Manufacturer Contact
diane christensen
one medline place
mundelein, IL 60060
8476434747
MDR Report Key5637598
MDR Text Key44663311
Report Number1417592-2016-00056
Device Sequence Number1
Product Code INM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Patient Family Member or Friend
Device Catalogue NumberMDS808200WX
Device Lot NumberU140607371
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 04/11/2016
Initial Date FDA Received05/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age77 YR
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