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U.S. Department of Health and Human Services

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

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AQUATEC OPERATIONS GMBH BATH LIFT 9153652083; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number 1471565
Device Problems Bent (1059); Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review.
 
Event Description
Provider states ring that holds actuator snapped in half, spring is bent.
 
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Brand Name
BATH LIFT 9153652083
Type of Device
LIFT, PATIENT, NON-AC-POWERED
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 Key5644218
MDR Text Key46168202
Report Number3007231105-2016-00056
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 04/04/2014
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 Number1471565
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/04/2014
Initial Date FDA Received05/10/2016
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 Number1
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