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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE Z CATHETER INTERFACE MODULE; SYSTEM, SIGNAL ISOLATION
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ZONARE MEDICAL SYSTEMS, INC VIEWMATE Z CATHETER INTERFACE MODULE; SYSTEM, SIGNAL ISOLATION Back to Search Results
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2021
Event Type  malfunction  
Event Description
The viewmate system do not recognize the ice catheter and a clinically significant delay occurred.The system was power cycled a couple times, the ice catheter was exchanged and the cim was used in different ports which did not resolve the issue.Another catheter was attempted which did not resolve the issue.Another cim was used to continue the procedure with no consequences to the patient.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be determined.
 
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Brand Name
VIEWMATE Z CATHETER INTERFACE MODULE
Type of Device
SYSTEM, SIGNAL ISOLATION
Manufacturer (Section D)
ZONARE MEDICAL SYSTEMS, INC
420 north bernardo avenue
mountain view CA 94043
MDR Report Key11414892
MDR Text Key244475661
Report Number3004189859-2021-00001
Device Sequence Number1
Product Code DRJ
Combination Product (y/n)N
PMA/PMN Number
K151175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/18/2021
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 Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/23/2021
Initial Date FDA Received03/04/2021
Supplement Dates Manufacturer Received03/17/2021
Supplement Dates FDA Received03/18/2021
Patient Sequence Number1
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