ZOLL NTP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-22 for ZOLL NTP manufactured by Zmi Corporation.

Event Text Entries

[242] A hewlett & packard defibrillator monitor was also in use at the time of the code. The model number is 43110. This device is fully functionalinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number491
MDR Report Key491
Date Received1992-04-02
Date of Report1992-03-27
Report Date1992-03-27
Date Reported to FDA1992-03-27
Date Added to Maude1992-05-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameZOLL NTP
Product CodeDRK
Date Received1993-11-22
Device Availability*
Device Age01-FEB-87
Implant Flag*
Device Sequence No1
Device Event Key484
ManufacturerZMI CORPORATION

Patients

Patient NumberTreatmentOutcomeDate
101. Death 1992-04-02
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