MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC. HOYER PRESENCE LIFT; PT LIFTER

Model Number HOY-PRESENCE

Device Problems Inadequate or Insufficient Training (1643); Device Handling Problem (3265)

Patient Problem Fall (1848)

Event Date 10/07/2014

Event Type  No Answer Provided  

Event Description

It was reported to the mfr by the facility ((b)(6)), per the facility, the resident was being transferred from a wheelchair to a shower chair.The resident was placed in the sling and the sling attached to the lift by two nurses' aides.The nurses' aides were moving the lift by using the lift handle and the bottom of the sling that the resident was seated in.The cradle tilted back and allowed the sling loop to slide off the hook.The resident fell out of the sling.The resident was transported to the hosp for eval/testing and returned to the facility the same with no injuries.The sling that was being used during the transport was manufactured by invacare.(b)(4) were entered into our sys to retrieve the lift and sling for investigation at joerns.As of this writing, the lift and sling have not been returned to joerns.

Manufacturer Narrative

Joerns sending the report to the mfr.

• Brand Name: HOYER PRESENCE LIFT
• Type of Device: PT LIFTER
• Manufacturer (Section D): APEX HEALTHCARE MFG INC.; min hsiung, chi yi ; TW
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4374519
• MDR Text Key: 20776330
• Report Number: 3009402404-2014-00020
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-PRESENCE
• Device Catalogue Number: HOY-PRESENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2014
• Distributor Facility Aware Date: 10/07/2014
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/15/2014
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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: 51 YR
• Patient Weight: 76