MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER HPL402 LIFT; PATIENT LIFT

Model Number HPL402

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

Patient Problem Fall (1848)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

This report or other information submitted by joerns healthcare under 21 cfr part 803, and any release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

Event Description

It was reported to the manufacturer by the end user, per the end user, patient arrived for regular scheduled dialysis treatment via wheelchair with nursing home hoyer sling pad placed under patient.Upon patient transfer from the wheelchair to the dialysis chair utilizing the joerns hoyer lift device with the nursing home hoyer sling pad, the patient fell backwards partially out of the hoyer sling pad.The patient hit his head landing on a staff member's foot and the floor.Patient did not lose consciousness.Patient complained of head and upper back pain.The 911 was called and patient was transferred and admitted to the hospital with a sub-arachnoid hemorrhage and fracture of left 6th rib.Upon speaking to the facility staff, it was mentioned that the sling was positioned half way down on the patient's back.After the incident, the biomed technician performed a pm on the lift and cleared it for use at the facility.Complaint# (b)(6) was entered into our system.

• Brand Name: HOYER HPL402 LIFT
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; no 20 industrial 3rd rd; tou chiac industrial park; min hsiung shiang, chia yi ; TW
• Manufacturer (Section G): APEX HEALTHCARE MFG INC; no 20 industrial 3rd rd; tou chiac industrial park; min hsiung shiang, chia yi ; TW
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7444620
• MDR Text Key: 105966540
• Report Number: 3009402404-2018-00020
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HPL402
• Device Catalogue Number: HPL402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 74 YR
• Patient Weight: 42