MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number R SERIES

Device Problem Failure to Convert Rhythm (1540)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to defibrilate a 62-year-old male patient, the device failed to cardiovert the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.The device logs, electrode pads and accessories used were not available for review.After reviewing facts provided by the customer, it was determined that the device met specification.The customer indicated that there was no conversion of a patient's rhythm after three synchronized cardioversion shocks of 200j.A failure to convert a rhythm is not a malfunction of the device as long as the unit delivers the shock, which this device did do each of the three times.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11050947
• MDR Text Key: 223043970
• Report Number: 1220908-2020-04127
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017200
• UDI-Public: 00847946017200
• Combination Product (y/n): N
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR