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

Model Number R SERIES

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed a "pacer fault 124".Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Concomitant medical device.Evaluation results: the devices was returned to zoll medical corporation; the customer's report was observed during review of the device's history logs.However, the reported problem could not be duplicated with the devices.The devices went through bench handling and pacer testing with no discrepancies found.The devices were recertified and returned to the customer.Review of the history logs shows that the user was pacing for approximately 1 minute before the error message was seen.The user then switched r series devices but kept the same patient circuit.After approximately 6 minutes into pacing with the second unit the same messages are seen again.The reported pacer warning 124 is a general warning to the user that indicates there is an issue with the pacing function.Note, that even when the messages appeared the device was still providing pacer pulses.It is noteworthy to mention the electrode pads and multi-function cable used at the time of the reported event were not returned for evaluation as part of this investigation.Analysis for reports of this type has not identified an increase in trend.Please reference medwatch report 1220908-2018-01328 for the second device used on the same patient.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed a "pacer fault 124" message.Clinicians obtained a second r-series device and utilized the same patient circuit (electrodes) already attached to the patient and the device displayed a "pacer fault 124" message.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: 7489996
• MDR Text Key: 107464671
• Report Number: 1220908-2018-01204
• 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,Followup
• Report Date: 04/16/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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