MAUDE Adverse Event Report: AQUATEC OPERATIONS GMBH BATH LIFT 9153652083; LIFT, PATIENT, NON-AC-POWERED

Model Number 1471651

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

As per tech service aquatec r handset is defective, light is flashing while on charge and buttons are not responding to demands.

• Brand Name: BATH LIFT 9153652083
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): AQUATEC OPERATIONS GMBH; alemannenstrabe 10; isny 8831 6; GM 88316
• Manufacturer (Section G): AQUATEC OPERATIONS GMBH; alemannenstrabe 10; isny 8831 6; GM 88316
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4590545
• MDR Text Key: 5480686
• Report Number: 3007231105-2015-00063
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1471651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• 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