MAUDE Adverse Event Report: INVACARE BATH LIFT 9153652083; LIFT, PATIENT, NON-AC-POWERED

Model Number 1471202

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

Broken actuator fixture.

• Brand Name: BATH LIFT 9153652083
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVACARE; one invacare way; elyria OH 44036
• Manufacturer (Section G): AQUATEC OPERATIONS GMBH; alemannenstrabe 10; isny 8831 6; GM 88316
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4321617
• MDR Text Key: 5131266
• Report Number: 3007231105-2014-00108
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1471202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/11/2014
• 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): Other