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

Model Number HOY-PRESENCE

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Fall (1848)

Event Date 11/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, patient was being lifted from the bed to a wheelchair.2 cna's where using a medium sling.When they turned the patient in the lift to put him in the wheelchair, the loop was 3/4 of the way on and the sling slipped off the hook.The safety latch bolt was bent and it allowed the loop to slip off.All the safety latches and bolts have been replaced.Complaint# (b)(4) was entered into our system.

• Brand Name: HOYER PRESENCE
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; no.6, industrial 2nd road; tou chiao industrial park; min hsiung shiang, chai yi hsien ; CH
• Manufacturer (Section G): APEX HEALTHCARE MFG INC; no.6, industrial 2nd road; tou chiao industrial park; min hsiung shiang, chai yi hsien ; CH
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 9608518
• MDR Text Key: 176079913
• Report Number: 3009402404-2020-00007
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• 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?: Yes
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Weight: 65