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

Model Number HOY-PRESENCE-S

Device Problem Inadequate or Insufficient Training (1643)

Patient Problems Fall (1848); Injury (2348)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

The facilities maintenance repaired the lift prior to notifying the manufacturer of the incident.

Event Description

It was reported to the manufacturer by the end user, per the end user, "a fall that they had while using a hoyer presence." upon speaking to the facility, the resident fell out of the sling while being moved in the lift.When the resident was picked-up, the strap came off the cradle.The resident fell out of the sling backwards, head first.The resident was sent to the hospital via 911 and sustained a laceration to the left back side of the head that required 8 staples.Complaint (b)(4) was entered into our system.

• Brand Name: HOYER PRESENCE
• Type of Device: ELECTRIC 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: 7605676
• MDR Text Key: 111191735
• Report Number: 3009402404-2018-00035
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nursing Assistant
• Device Model Number: HOY-PRESENCE-S
• Device Catalogue Number: HOY-PRESENCE-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2018
• 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: 84 YR
• Patient Weight: 79