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

Model Number MSERIES CCT

Device Problems Unable to Obtain Readings (1516); Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional pro code: mkj.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that during functional testing, the device displayed a "poor pad contact" message and inappropriately shut down.Complainant did not indicate that there was any patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical (b)(4); the reported malfunction for device shut down was duplicated and the ac power cord was replaced to remedy the problem.The device was recertified and returned to the customer.The reported malfunction for device displayed "poor pad contact" was evaluated and communication with the customer indicated there were no electrode pads attached at the time.This is normal operation of the device if there are no pads connected to the device.No trend is associated with reports of this type.

• 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: 9177476
• MDR Text Key: 161984653
• Report Number: 1220908-2019-03024
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00847946014421
• UDI-Public: 00847946014421
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/18/2019

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: Other
• Device Model Number: MSERIES CCT
• Device Catalogue Number: M SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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