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

Model Number HPL402

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, hemodialysis patient attended regularly scheduled dialysis treatment.Patient arrived in wheelchair with an unknown nursing home hoyer sling pad placed under the patient.Patient was transferred from the wheelchair to the dialysis chair using a hoyer lift device with a hoyer sling pad.During patient transfer the strap on the left leg portion of the hoyer sling pad broke causing the patient to fall and roll out of the hoyer sling pad onto the floor.The patient hit her left side causing left rib pain and left-hand knuckle pain.911 was called, patient was assisted to the dialysis chair.Patient declined er transfer.Dialysis treatment was performed and completed.Patient was discharged from dialysis facility and transferred back to nursing home.Chest ct scan- revealed minimally displaced fracture of left 6th rib.Upon communicating with the dialysis facility, they were unable to provide the manufacturer, model or serial number for the sling that was involved in the incident.The sling was transferred back to the living facility with the patient and they are also unable to provide any information about the sling.Complaint# 1118165 was entered into our system.

• Brand Name: HPL402
• 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 ; TW
• Manufacturer (Section G): APEX HEALTHCARE MFG INC; no.6, industrial 2nd road; tou chiao industrial park; min hsiung shiang, chai yi hsien ; TW
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, tx ; 8260270331
• MDR Report Key: 10049794
• MDR Text Key: 190750793
• Report Number: 3009402404-2020-00023
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HPL402
• Device Catalogue Number: HPL402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• 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 Age: 73 YR
• Patient Weight: 124