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

Model Number R SERIES

Device Problem Pacing Problem (1439)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by zoll medical corporation.The reported malfunction was not able to be duplicated or confirmed with the device.Troubleshooting the device included bench handling and full functionality testing which yielded no discrepancies.Review of the device log indicates multiple pd core warning which indicates poor patient to electrode coupling.The clinical log file was not available for review, but we can confirm no device faults, other than coupling, was identified in the activity logs.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown) the device was unable to pace.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 8761015
• MDR Text Key: 150030864
• Report Number: 1220908-2019-01806
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 00847946017521
• UDI-Public: 00847946017521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1