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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM CODMAN VPV PROGRAMMER REVISED; VPV SYSTEM
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RAYNHAM CODMAN VPV PROGRAMMER REVISED; VPV SYSTEM Back to Search Results
Catalog Number 823192R
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that a hakim programmer was not working and just kept spinning.Another programmer was brought in to verify the patient.This occurred during a procedure and caused a delay over 30 minutes.
 
Event Description
N/a.
 
Manufacturer Narrative
(b)(4).Sample was returned to san diego service center for failure analysis.Reason for return: vpv programmer wouldn't program.The console was evaluated for reported failure.The results were unconfirmed.The technician performed the resetting of the unit and performed the functional test.All tests passed.The technician was unable to verify the customer complaint.Manufacturing records were reviewed and found no anomalies.Based on the results of the investigation, the reported issue is not confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
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Brand Name
CODMAN VPV PROGRAMMER REVISED
Type of Device
VPV SYSTEM
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key8610289
MDR Text Key145082718
Report Number1226348-2019-00146
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K061876
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number823192R
Device Lot Number1266187
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Date Manufacturer Received06/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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