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

Model Number X SERIES

Device Problem Failure to Capture (1081)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2019

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 pace a patient (age & gender unknown), the device failed to capture the patient's heart rhythm.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The customer's report was observed during initial testing.However, the reported problem could not be verified because of the intermittent nature.The device was put through extensive testing including bench handling, stress testing, full functionality testing, and ecg testing, and defib/pacer testing with the customer's cables and a simulator without success.The processor/bridge/pace board was replaced as a precaution.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• 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: 9439830
• MDR Text Key: 169925708
• Report Number: 1220908-2019-03762
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 00847946019181
• UDI-Public: 00847946019181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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