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 Number: MW1012826
• MDR Report Key: 144899
• Date Received: 1998-01-16
• Date of Report: 1998-01-16
• Date of Event: 1998-01-16
• Date Added to Maude: 1998-01-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZAP-GUARD
• Generic Name: STERILE DEFIBRILLATOR SYSTEM TEST PROBE
• Product Code: DRL
• Date Received: 1998-01-16
• Model Number: NA
• Catalog Number: 91766
• Lot Number: 7112M
• ID Number: OUR STOCK #10783
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 141276
• Manufacturer: GUARDIAN ANGEL PRODUCTS, INC.
• Manufacturer Address: 2771 PHILMONT AVE. HUNTINGTON VALLEY PA 19006 US
• Baseline Brand Name: ZAP GUARD
• Baseline Generic Name: DEFIBRILLATOR TEST PROBE
• Baseline Model No: 91766
• Baseline Catalog No: 91766
• Baseline ID: NONE
• Baseline Device Family: TEST PROBE
• Baseline Shelf Life Contained: A
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K896985
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-01-16