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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H700150
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.¿ further information was requested but not received.
 
Event Description
During the procedure, the amplifier did not communicate as expected.Troubleshooting did not resolve the issue, the amplifier beeped continuously and the case was cancelled.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the amplifier serial number was not provided.Based on the information received, the cause of the reported incident communication issue and subsequent cancellation remains unknown.
 
Manufacturer Narrative
Additional information: one workmate claris amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels had no physical damage.All of the mounting hardware was secured.The returned workmate claris amplifier was powered on but no communication was established with the test computer.The single board computer (sbc) was temporarily replaced with a known good sbc board and successful communication was established.Using the test standard sbc board, the amplifier was run for few hours and no interrupted or loss of communication was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided and the investigation performed, the reported event was due to a non-functional sbc board.
 
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Brand Name
WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key8974100
MDR Text Key156881983
Report Number2184149-2019-00164
Device Sequence Number1
Product Code DQK
UDI-Device Identifier05415067001504
UDI-Public05415067001504
Combination Product (y/n)N
PMA/PMN Number
K132073
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberH700150
Device Catalogue NumberH700150
Device Lot Number5771555
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/20/2019
Initial Date FDA Received09/09/2019
Supplement Dates Manufacturer Received10/16/2019
12/06/2019
Supplement Dates FDA Received10/22/2019
12/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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