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

Model Number HOY-PRESENCEWSC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

This report or other information submitted by (b)(6) healthcare under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by (b)(6) healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

Event Description

It was reported to the manufacturer, by the end user, per the end user, that the nursing staff informed their administrator, that "two individuals who were using the lift as intended: raising the patient from the wheelchair, positioning her to return to bed.While in the elevated position, a sudden loud bang occurred, and the lift unexpectedly descended at a faster than normal speed without the caregivers pressing the lower button." the patient, weighing 250lbs, was promptly sent to the hospital due to concerns about potential injuries.An internal investigation at the summit of plantsville is underway, involving the collection of written statements.During a demonstration of the emergency lockout feature by the administrator and the physical plant director, those present noted a significant difference from the incident - "a loud bang followed by a faster than normal speed drop"; noting that the emergency lock out feature was a normal speed and unlike the incident.At present, "no external damage is visible on the lift" according to administrator and the physical plant director.Complaint (b)(4) and (b)(4) were entered into our system to have the lift returned for investigation.As of this writing, the lift has not been returned.

• Brand Name: HOYER LIFT
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG. INC; no. 6 industrial 2nd road; tou chiao industrial park; min hsuing, chai yi hsi ; TW
• Manufacturer (Section G): APEX HEALTHCARE MFG. INC; no. 6 industrial 2nd road; tou chiao industrial park; min hsuing, chai yi hsi ; TW
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 19085610
• MDR Text Key: 339990802
• Report Number: 3009402404-2024-00013
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-PRESENCEWSC
• Device Catalogue Number: HOY-PRESENCEWSC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2024
• 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): Other
• Patient Sex: Female