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

Model Number MSERIES CCT

Device Problem Unable to Obtain Readings (1516)

Patient Problem Death (1802)

Event Date 02/23/2019

Event Type  Death  

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 treat a patient (age & gender unknown), the device displayed a "defib pad short" message.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device with multi-function cable were put through extensive testing including bench testing, impedance testing, defib cycle tests and various defib energies without duplicating the report.The device passed internal visual inspections.The device was recertified and returned to the customer.The electrodes involved were returned and visual inspection did not find any evidence that would inhibit the pads from shocking or causing a defib pad short condition.The electrodes were subjected to multiple discharge tests and the results were within specification.No data card was used during the event and no clinical logs were available as part of this investigation.Analysis of 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: 8501570
• MDR Text Key: 141524751
• Report Number: 1220908-2019-00928
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00847946004811
• UDI-Public: 00847946004811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/02/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• 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
• Patient Outcome(s): Death