MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number R SERIES

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Cardiac Arrest (1762); Ventricular Tachycardia (2132)

Event Date 11/15/2019

Event Type  malfunction  

Event Description

Adult male scheduled for elective cabg.Patient arrived to operating room @1313pm.When or circulator return from lunch around 1430pm patient was critical and operating room team was coding patient.Patient went into vt rhythm and need to be shocked.Nurse went to deliver shock to patient; using ap pads and zoll defibrillator machine did not fire off shock to patient.Appropriate sounds were heard for charging defibrillator.Nurse attempted to deliver 2 shocks to patient; shock finally delivered on third attempt.Approximately 5 to 10 minutes later failed shocks x2.Shock finally delivered on third attempt.Preoperative diagnosis: coronary artery disease.Cardiomyopathy with ef 10%, cardiac arrest in or requiring cpr.Procedures: emergency coronary artery bypass grafting x4 using left internal mammary artery to the mid left anterior descending (lad) and reverse greater saphenous vein grafting to the first om, second obtuse marginal and posterior lateral branch of rca.Endoscopic vein harvesting from the left lower extremity.Placement of iabp via right femoral artery.Intraoperative transesophageal echocardiogram.Patient was transferred to out-of-state cardiac care and placed on ecmo.Below is that institute's case.Description of patient and diagnosis: adult male with coronary artery disease and ischemic cardiomyopathy (lvef 10%) status post emergent cabg, iabp, impella, and va ecmo at osh admitted for ongoing management.The patient was admitted to an osh 3 days before and underwent emergent cabg x4 (lima to lad; reverse gsv to om1, om2, and posterior-lateral branch of the rca) complicated by periop cardiac arrest and iabp placement.The patient suffered recurrent cardiac arrest requiring acls, removal of the iabp, and placement of impella and va ecmo.He was subsequently transferred to the cvicu.Manufacturer response for defibrillator/pacer, zoll medical corporation (per site reporter).No response yet from technical support so far.They've asked if a patient was involved - to which we answered "yes".

• Brand Name: R SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9665489
• MDR Text Key: 177629037
• Report Number: 9665489
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R SERIES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 82