ZAP-GUARD 91766

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-16 for ZAP-GUARD 91766 manufactured by Guardian Angel Products, Inc..

Event Text Entries

[75394] Sterile defibrillator sys test probe punctures packaging material. Metal tips of probe puncture outside of packaging materials. Packaging has changed from heavy plastic and tyvak to pvc and tyvak material.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1012826
MDR Report Key144899
Date Received1998-01-16
Date of Report1998-01-16
Date of Event1998-01-16
Date Added to Maude1998-01-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameZAP-GUARD
Generic NameSTERILE DEFIBRILLATOR SYSTEM TEST PROBE
Product CodeDRL
Date Received1998-01-16
Model NumberNA
Catalog Number91766
Lot Number7112M
ID NumberOUR STOCK #10783
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key141276
ManufacturerGUARDIAN ANGEL PRODUCTS, INC.
Manufacturer Address2771 PHILMONT AVE. HUNTINGTON VALLEY PA 19006 US
Baseline Brand NameZAP GUARD
Baseline Generic NameDEFIBRILLATOR TEST PROBE
Baseline Model No91766
Baseline Catalog No91766
Baseline IDNONE
Baseline Device FamilyTEST PROBE
Baseline Shelf Life ContainedA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK896985
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-01-16

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