MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER POWER LIFT WITH SCALE; ELECTRIC PATIENT LIFT

Model Number HPL402

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848); Swelling (2091)

Event Date 03/03/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user the patient was being transferred from the portable commode to the hospital bed and the main bolt came out of the lift.The patient dropped to the floor and landed on his buttocks.The patient sustained the following injuries: bruising to the buttocks, right hand and scrotum area; swelling to the right hand and buttocks; skin tears and bleeding on the buttocks.The caregiver performed an assessment on the patient and contacted the nurse to come to the residence to evaluate the patient.Due to the patients condition, he was unable to leave the residence to receive medical attention.Hospice arranged for a mobile x-ray unit to go to the residence and perform x-rays as part of the evaluation.Complaint# (b)(4).Were entered into our system to have the lift and scale returned to joerns for investigation.As of the writing, the lift and scale has not been returned.

Manufacturer Narrative

(b)(4).

• Brand Name: HOYER POWER LIFT WITH SCALE
• 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: 4681753
• MDR Text Key: 20457491
• Report Number: 3009402404-2015-00009
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HPL402
• Device Catalogue Number: HPL402
• 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: 04/01/2015
• Distributor Facility Aware Date: 03/03/2015
• Device Age: 12 MO
• Event Location: Home
• Date Report to Manufacturer: 04/01/2015
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 78 YR
• Patient Weight: 62