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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTHCARE MFG, INC DRIVE; PATIENT LIFT, ELECTRONIC
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APEX HEALTHCARE MFG, INC DRIVE; PATIENT LIFT, ELECTRONIC Back to Search Results
Model Number 13242
Device Problems Component Missing (2306); Material Deformation (2976)
Patient Problems Fall (1848); Hip Fracture (2349)
Event Date 06/15/2021
Event Type  Injury  
Event Description
Drive devilbiss is the initial importer of the device which is an electronic patient lift.We are awaiting return of the device for evaluation.We have received photos of the device.When additional information is received a follow-up submission will be tendered.The facility stated the patient lift malfunctioned during operation and the resident fell.The incident occurred while transferring the patient from a bed to a wheelchair.Lift shows signs of bent metal and bolt missing where the boom connects to mast.The lift is inoperable.The resident suffered a hip fracture.Unit was used for approximately 16 months.Unit was used by multiple patients.
 
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Brand Name
DRIVE
Type of Device
PATIENT LIFT, ELECTRONIC
Manufacturer (Section D)
APEX HEALTHCARE MFG, INC
no. 6, industrial 2nd road
tou chiao industrial park,
min hsiung, shiang chiayi
TW 
MDR Report Key12204874
MDR Text Key262742412
Report Number2438477-2021-00032
Device Sequence Number1
Product Code FSA
UDI-Device Identifier00822383125633
UDI-Public822383125633
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number13242
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/21/2021
Distributor Facility Aware Date06/18/2021
Device Age3 YR
Event Location Nursing Home
Date Report to Manufacturer08/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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