MAUDE Adverse Event Report: MONARCH CEILING LIFT

Model Number	M929241
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	09/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Savaria was informed that one of their manufactured ceiling mounted, patient transfer xy system (monarch) pulled out of the ceiling.The caregiver was hit in the head when the rail came down but did not need medical attention.The investigation was completed and the manufacturer found: the installation was done by a trained dealer (third party) who admitted changing the installation method at the last minute.Pictures showed that the hardware (lag bolts) that was used by the installer (not specified by the manufacturer) pulled out from the house wooden structure.Dealer said they conducted the initial weight load test (not documented) but did not detect any anomalies at commissioning.The installation was redone properly and a weight tested the day after the event.No medical attention or emergency services were required after the incident.

• Brand Name: MONARCH CEILING LIFT
• Common Device Name: CEILING LIFT
• MDR Report Key: 12675186
• Report Number: 3005753836-2021-00001
• Device Sequence Number: 14698777
• Product Code: FSA
• UDI-Device Identifier: 10688503241006
• UDI-Public: 10688503241006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: M929241
• Device Catalogue Number: M929241
• Device Lot Number: SF0000488
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 16 YR