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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TZ MEDICAL PATIENT COMPANION V1 MULTI-PORT CONNECTOR; BOOKER BOX
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TZ MEDICAL PATIENT COMPANION V1 MULTI-PORT CONNECTOR; BOOKER BOX Back to Search Results
Model Number V1-MPC
Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)
Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Event Date 01/20/2020
Event Type  Injury  
Event Description
The pt presented for repeat ablation.Cardioversion using zoll unsuccessful therefore booker box employed for internal cardioversion.The pt developed ventricular fibrillation requiring brief cpr and vasopressor therapy.Circulation was restored and the pt stabilized.The tech contacted the mfr rep and learned that limb leads are required for internal cardioversion via the booker box.Cardioversion was not complete, however nsr was restored and the pt was discharged home in good condition to be followed by cardiology.
 
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Brand Name
PATIENT COMPANION V1 MULTI-PORT CONNECTOR
Type of Device
BOOKER BOX
Manufacturer (Section D)
TZ MEDICAL
portland OR
MDR Report Key9726439
MDR Text Key180336278
Report Number9726439
Device Sequence Number1
Product Code DSA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model NumberV1-MPC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2020
Distributor Facility Aware Date01/20/2020
Device Age12 MO
Event Location Hospital
Date Report to Manufacturer01/31/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/18/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age66 YR
Patient Weight113
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