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

Model Number MSERIES CCT

Device Problem Pacing Problem (1439)

Patient Problem No Information (3190)

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 was unable to function as intended in the pacing mode.This is all the information available.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was evaluated by zoll medical corporation.The reported malfunction was not duplicated or confirmed.The device was subjected to extensive troubleshooting which included full functionality testing without duplicating the reported malfunction.The device was recertified and returned to the customer.Its important to mention the device reacted to drop in hr which is normal.Its unknown why the drop in hr occurred and if it was symptomatic of the patience's condition.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: M 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: 8903513
• MDR Text Key: 154713999
• Report Number: 1220908-2019-02327
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• PMA/PMN Number: K011865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MSERIES CCT
• Device Catalogue Number: M SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• 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