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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 MDS808200SLRR
Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)
Patient Problems Death (1802); Bone Fracture(s) (1870)
Event Date 01/26/2016
Event Type  Death  
Manufacturer Narrative
The son of the end user reported that his mother was a resident in a skilled nursing facility.While sitting in a transport chair, a nurse was attempting to lift his mother's legs onto a stool.The chair apparently tipped backwards and she fell, suffering multiple vertebral fractures.She subsequently died.We have limited information pertaining to this incident as the son indicated he received conflicting reports from the facility and the coroner.He stated that he evaluated the transport chair and could not find any evidence to suggest the device caused the incident.It is unknown if the brakes were engaged or if anyone was standing behind the transport chair to secure its position while the end user's legs were being lifted.The owner's manual addresses center of gravity, balance and stability.It indicates that the center of gravity must be maintained and that loss of proper balance may cause the transport chair to tip over.The sample has not been returned for evaluation and a root cause has not been determined.We have no information to suggest the existence of any manufacturing defect.We cannot rule out user error as a potential root cause.Due to the reported incident and in an abundance of caution, this medwatch is being filed.
 
Event Description
The son of the end user reported that his mother was a resident in a skilled nursing facility.While sitting in a transport chair, a nurse was attempting to lift his mother's legs onto a stool.The chair apparently tipped backwards and she fell, suffering multiple vertebral fractures.She subsequently died.
 
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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 Key5461346
MDR Text Key39081077
Report Number1417592-2016-00013
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 consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2016
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 Nurse
Device Catalogue NumberMDS808200SLRR
Was Device Available for Evaluation? No
Event Location Nursing Home
Initial Date Manufacturer Received 01/29/2016
Initial Date FDA Received02/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Death; Other;
Patient Age93 YR
Patient Weight59
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