MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL R SERIES

Model Number 45437

Device Problems Component Falling (1105); Defibrillation/Stimulation Problem (1573); Defective Device (2588)

Patient Problems Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Vascular System (Circulation), Impaired (2572)

Event Date 09/18/2019

Event Type  Injury  

Event Description

Pt admitted for avr redo sternotomy.At the end of the case, the external defibrillator pad wires were cut as drapes were being removed.At 1731 the pt exhibited ventricular tachycardia.Surgeon initiated cpr at 1732, saline pads and hard paddles given to the surgical field at this time.Charge nurse contacted.Surgical nurse charged r-series zoll to 120 joules.Charge button pushed with no delivery of shock.Shock attempted two more times with external paddles.External 'pro pads' stuck to pt.Shock delivered at 120 j.Pt returned to a-v paced rhythm.Per operating room mgr, zoll checks had been done less than 24 hours prior to event and checks had passed.

• Brand Name: ZOLL R SERIES
• Type of Device: ZOLL R SERIES
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; chelmsford MA
• MDR Report Key: 9139945
• MDR Text Key: 161336126
• Report Number: 9139945
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2019
• Distributor Facility Aware Date: 09/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Weight: 85