PATIENT COMPANION V1 MULTI-PORT CONNECTOR V1-MPC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for PATIENT COMPANION V1 MULTI-PORT CONNECTOR V1-MPC manufactured by Tz Medical.

Event Text Entries

[180336278] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	9726439
MDR Report Key	9726439
Date Received	2020-02-18
Date of Report	2020-01-30
Date of Event	2020-01-20
Date Facility Aware	2020-01-20
Report Date	2020-01-30
Date Reported to FDA	2020-01-31
Date Reported to Mfgr	2020-01-31
Date Added to Maude	2020-02-19
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	0
Reprocessed and Reused Flag	3
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	3

Device Details

Brand Name	PATIENT COMPANION V1 MULTI-PORT CONNECTOR
Generic Name	BOOKER BOX
Product Code	DSA
Date Received	2020-02-18
Model Number	V1-MPC
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	12 MO
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0
Manufacturer	TZ MEDICAL
Manufacturer Address	PORTLAND OR US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening	2020-02-18