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

Model Number MSERIES BI-PHASIC

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during biomed testing, the device was unable to obtain an ecg signal via electrode pads. Complainant indicated that there was no patient involvement in the reported 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 full ecg functionality testing using the returned multifunctional cable without duplicating the malfunction. The device also passed the patient impedence calibration test. The device was recertified and returned to the customer. 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: 8084166
• MDR Text Key: 127553683
• Report Number: 1220908-2018-03395
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K990762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/19/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER
• Device MODEL Number: MSERIES BI-PHASIC
• Device Catalogue Number: M SERIES
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 09/01/2006
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse