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

Model Number 1525771

Device Problems Break (1069); Sticking (1597); Difficult or Delayed Activation (2577)

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

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dealer already replaced 1 caster because it broke.The remaining three are very stiff and hard to lock.

• 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: 5317571
• MDR Text Key: 34774746
• Report Number: 3007231105-2015-00174
• Device Sequence Number: 1
• Product Code: ILS
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1525771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• 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