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

Model Number HOY-PRESENCE

Device Problems Detachment of Device or Device Component (2907); Misassembly by Users (3133)

Patient Problems Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

Event Date 11/28/2014

Event Type  Injury  

Event Description

It was reported to the manufacturer by the facility, (b)(6), per the facility during transfer in residents' room, while resident was supported in sling/cradle with three staff people present, lift separated at cradle bolt.Resident fell to the floor and the cradle landed on top of her.The resident was sent to the er for testing and evaluation.The resident sustained a laceration to the back of her head, right flank bruising and right eye/facial bruising.The resident returned to the facility the same day.Complaint# (b)(4) have been entered into our system to retrieve the lift for investigation at joerns.As of this writing, the lift has not been returned to joerns.

• Brand Name: HOYER PRESENCE LIFT
• Type of Device: ELECTRIC PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; min hsiung; chi yi ; TW
• Manufacturer (Section G): JOERNS HEALTHCARE; 2100 design rd; arlington TX 76014 000
• Manufacturer Contact: felecia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4377190
• MDR Text Key: 22152325
• Report Number: 3009402404-2014-00023
• 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: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/16/2014
• Distributor Facility Aware Date: 11/28/2014
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/16/2014
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2006
• 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: 95 YR
• Patient Weight: 64