MAUDE Adverse Event Report: APEX HEALTH CARE 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.Complaint#(b)(4) has been entered into our system.This lift has not yet returned as of this writing.

Event Description

We received the mdr event from our usa customer and it stated as below: 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 cam 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 (b)(6) system.

• Brand Name: HOYER PRESENCE
• Type of Device: ELECTRIC PATIENT LIFT,
• Manufacturer (Section D): APEX HEALTH CARE MFG., INC.; no.6 industrial 2nd road,; tou chiao industrial park,; ming hsiung shiang, chai yi, taiwan 62152 ; TW 62152
• Manufacturer (Section G): APEX HEALTH CARE MFG., INC.; no.6 industrial 2nd road,; tou chiao industrial park,; ming hsiung shiang, chai yi, taiwan 62152 ; TW 62152
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7946233
• MDR Text Key: 123055760
• Report Number: 3010605276-2018-00007
• 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: health professional
• Reporter Occupation: Other
• 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: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HOY-PRESENCE-S
• Device Catalogue Number: HOY-PRESENCE-S
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2018
• 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: 84 YR
• Patient Weight: 79