Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTH CARE MFG., INC. DIRECT SUPPLY; PATIENT LIFT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APEX HEALTH CARE MFG., INC. DIRECT SUPPLY; PATIENT LIFT Back to Search Results
Model Number DS-13242
Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 01/26/2017
Event Type  Injury  
Event Description
(b)(4) received notification regarding an incident at the (b)(6) involving a patient lift that (b)(4) imports and distributes for a private label customer, direct supply.The patient was being lowered from the patient lift by two certified nursing assistants, when allegedly the left side sling loop slipped out of the lift hook causing her to fall 2-3 feet to the floor.The patient was taken to the er where the initial diagnosis showed a fractured right femur however, it lead to an (b)(6) confirmed the sling was not ripped and the lift hooks were not broken.According to engineers at (b)(6), they discovered that the hook clip was not functioning properly therefore the sling loop may have slipped out.Drive has requested the patient lift for internal evaluation but was declined because (b)(6) does not want to release the item.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DIRECT SUPPLY
Type of Device
PATIENT LIFT
Manufacturer (Section D)
APEX HEALTH CARE MFG., INC.
no.20 industrial 3rd road
tou chiao
industrial park, chiayi county 621
TW 
MDR Report Key6770727
MDR Text Key81956817
Report Number2438477-2017-00019
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 02/27/2017,01/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nursing Assistant
Device Model NumberDS-13242
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/27/2017
Distributor Facility Aware Date01/30/2017
Device Age7 MO
Event Location Nursing Home
Date Report to Manufacturer02/27/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight91
-
-