MAUDE Adverse Event Report: SAVARIA CONCORD LIFTS INC. MONARCH FIXED CEILING LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number M929101-02

Device Problems Defective Component (2292); Device-Device Incompatibility (2919); Installation-Related Problem (2965); Device Fell (4014)

Patient Problem Bruise/Contusion (1754)

Event Date 07/10/2020

Event Type  Injury  

Event Description

Savaria was informed that one of their monarch ceiling lifts was installed on a non-compatible track system and the track system failed resulting in the unit falling on the patient/nurse.Investigation allows to conclude that the dealer (third party installer) didn't follow the installation instructions.The ceiling lift fell from the turntable during operation, the turntable guards is not being adapted for the lift to prevent the fall.Medical device was installed despite incompatibility: the manufacturer was not aware of the transaction before hand.The manuals on the monarch lift clearly state that it must never be installed on a competitors track system with any turntable or switching option.The patient and nurses were hit by the falling ceiling lift.Manufacturer was informed that patient and nurses had minor bruises on the arms, checked at hospital and quickly released.The device was sold/installed by a local dealer.Fda safety report id# (b)(4).

• Brand Name: MONARCH FIXED CEILING LIFT
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): SAVARIA CONCORD LIFTS INC.; brampton, on L6T5E 1; CA L6T5E1
• MDR Report Key: 10338871
• MDR Text Key: 200821758
• Report Number: MW5095782
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M929101-02
• Device Catalogue Number: M929101-02
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR
• Patient Weight: 64