MAUDE Adverse Event Report: AQUATEC OPERATIONS GMBH ALL-IN-ONE COMMODE 9153629772; ADAPTOR, HYGIENE

Model Number 9630-1

Device Problem Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

Event Description

Dealer is stating that the provider states that the unit is uneven.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: commodes.Frame/structure, uneven/wobbly.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the commode being uneven without a load, but once a load was applied the unevenness went away.As to why the commode was uneven could not be determined.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: commodes.Frame/structure, uneven/wobbly.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the commode being uneven without a load, but once a load was applied the unevenness went away.As to why the commode was uneven could not be determined.Dealer is stating that the provider states that the unit is uneven.

• Brand Name: ALL-IN-ONE COMMODE 9153629772
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): AQUATEC OPERATIONS GMBH; alemannenstrasse 10; isny 88316 ; GM 88316
• Manufacturer (Section G): AQUATEC OPERATIONS GMBH; alemannenstrasse 10; isny 88316 ; GM 88316
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5311024
• MDR Text Key: 34667688
• Report Number: 3007231105-2015-00173
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9630-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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