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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTHCARE MFG., INC. DRIVE MEDICAL; LIFT, PATIENT, AC-POWERED
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APEX HEALTHCARE MFG., INC. DRIVE MEDICAL; LIFT, PATIENT, AC-POWERED Back to Search Results
Model Number 13245
Device Problems Labelling, Instructions for Use or Training Problem (1318); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/04/2016
Event Type  Injury  
Event Description
(b)(4) received notice about this claim from (b)(6) (nursing home), involving a patient lift, a product imported and distributed by (b)(4).While the enduser was being transferred from the wheelchair to the bed, the lift allegedly made a popping noise before the loop from the sling slid off the lift cradle causing the enduser to fall to the floor.The enduser fractured his t9 vertebrae in his back.This report is based on the information that was provided by (b)(6).
 
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Brand Name
DRIVE MEDICAL
Type of Device
LIFT, PATIENT, AC-POWERED
Manufacturer (Section D)
APEX HEALTHCARE MFG., INC.
no. 6, industrial 2nd rd
tou chiao industrial park
min hsiung chiayi,
TW 
MDR Report Key6153203
MDR Text Key61697830
Report Number2438477-2016-00061
Device Sequence Number1
Product Code FNG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/07/2016,11/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nursing Assistant
Device Model Number13245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2016
Distributor Facility Aware Date11/09/2016
Device Age1 YR
Event Location Nursing Home
Date Report to Manufacturer12/07/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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