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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPASS HEALTH BRANDS RICHMAR; AUTOSOUND 5.6
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COMPASS HEALTH BRANDS RICHMAR; AUTOSOUND 5.6 Back to Search Results
Model Number 400-002
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The wire is broken under the flex nut.The ground wire is an exposed wire.The rest have the coating still on them.
 
Event Description
Return inspection: complaint confirmed.The wire for the autosound applicator was damaged causing the unit to not be functional.The wires that run from the unit to the autosound applicator were cut.They were not visible until the cable for the autosound applicator was removed from the unit because the wire got cut right were it goes into the unit and the strain relief was covering the cut part of the wire.The wire was repaired.The transducers for the autosound applicator were very pitted and had no output.The transducers were replaced.After repairs the autosound applicator output was calibrated then the device was tested and passed all tests.
 
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Brand Name
RICHMAR
Type of Device
AUTOSOUND 5.6
Manufacturer (Section D)
COMPASS HEALTH BRANDS
6753 engle road
middleburg heights 44130
MDR Report Key10958518
MDR Text Key220242625
Report Number3012316249-2020-00039
Device Sequence Number1
Product Code IMG
Combination Product (y/n)N
PMA/PMN Number
K032941
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number400-002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Date Manufacturer Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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