MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER ELECTRIC PATIENT LIFT

Model Number HOY-ADVANCE-E

Device Problems Crack (1135); Device Inoperable (1663); Positioning Problem (3009)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 12/14/2013

Event Type  Injury  

Event Description

It was reported to the mfr by the home-user (b)(6), per the home-user (b)(6) (wife) was lifting (b)(6) (step-father) from the bed.(b)(6) was in a sitting position, fully lifted (height) and away from the bed.The lift fell over.(b)(6) landed on the floor with the lift on top of him.(b)(6) was able to get the lift off of (b)(6), but not able to assist (b)(6) up off the floor.(b)(6) called 911 and (b)(6) was transported to the (b)(6) er.At the er, (b)(6) had a full body evaluation for any injuries.(b)(6) had a bruise on his foot, knee, left arm and elbow.(b)(6) was released to return home later that same day.(b)(4) was entered into our system.

Manufacturer Narrative

Joerns sending the report to the mfr.

• Brand Name: HOYER ELECTRIC PATIENT LIFT
• Type of Device: ELECTRIC PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; min hsiung; chi yi ; TW
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014-0000 ; 8008260270
• MDR Report Key: 3627918
• MDR Text Key: 4184765
• Report Number: 3009402404-2014-00003
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/05/2014

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: Lay User/Patient
• Device Model Number: HOY-ADVANCE-E
• Device Catalogue Number: HOY-ADVANCE-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2014
• Distributor Facility Aware Date: 12/14/2013
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 02/05/2014
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 91 YR
• Patient Weight: 113