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

Model Number R SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing which included bench handling and ecg functional testing without duplicating the malfunction.Review of the device activity log showed an "ecg fault 7" message.As a precaution, the analog board was replaced to remedy the malfunction.The device was recertified and returned to the customer.No trend is associated with reports of this type.

Event Description

Complainant alleged that during a routine shift check by a clinician, the device displayed an "ecg fault 7" message.Complainant indicated that there was no patient involvement in 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: 9162612
• MDR Text Key: 161424608
• Report Number: 1220908-2019-03086
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00847946002336
• UDI-Public: 00847946002336
• 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: 09/16/2019

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: 09/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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