ZOLL M-SERIES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for ZOLL M-SERIES manufactured by Zoll Medical Corp..

Event Text Entries

[137593980] Patient found unresponsive and not breathing. Code blue called, and response team arrived with crash cart. Defibrillator cardiac monitoring pads applied and machine turned on, asystole per zoll monitor ((b)(4)). Medications administered per physician, patient converted to rhythm v-fib. Defibrillator pads put on patient, attempted charge to 120j and monitor showed? Defib pad short? , changed, adjusted pads and attempted charge again. The same message code,? Defib pad short? Was experienced with the second set of pads. Brought second defibrillator ((b)(4)) to bedside, connected pads, put pads on patient, attempted charge, monitor read? Defib pad short? ; changed pads and moved pad location (one on back/one over heart), changed cables, attempted charge, monitor read? Defib pad short?. Chest compressions continued on patient and medications administered. After coding patient for 25 minutes, patient death declared by physician in attendance. After event, both defibrillators tested and test results were positive, showing the machines were ready for use. Biomed tested both devices on 20 feb 2019 , both tested in workable condition. According to both physicians involved in the cardiac resuscitation event, the patient's pathophysiology likely resulted in the inability to create the appropriate conduction secondary to ascites, anasarca, liver and kidney disease.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8382081
• MDR Report Key: 8382081
• Date Received: 2019-02-25
• Date of Report: 2019-02-25
• Date of Event: 2019-02-15
• Date Facility Aware: 2019-02-15
• Report Date: 2019-02-22
• Date Reported to FDA: 2019-02-20
• Date Reported to Mfgr: 2019-02-19
• Date Added to Maude: 2019-03-01
• 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: 3
• Reprocessed and Reused Flag: 3
• 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: ZOLL M-SERIES
• Generic Name: DEFIBRILLATOR
• Product Code: DRK
• Date Received: 2019-02-25
• Model Number: M-SERIES
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 12 YR
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZOLL MEDICAL CORP.
• Manufacturer Address: CHELMSFORD MA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2019-02-25