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 Death (1802)

Event Date 02/15/2019

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) year-old male patient, the device displayed a "defib pad short" message.Complainant indicated that the clinician obtained another device and electrode pads to continue treating the patient and received the same error.Complainant indicated that the patient subsequently expired.Please reference medwatch report 1220908-2019-00648 for the another defibrillator used in the event.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the complainant was contacted for return of the device.The customer has responded and indicated the device is working fine and the will not be returning to zoll.

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, multiple 30 joules self-tests, shock testing at various joules settings utilizing the returned multifunction cable and continuity testing without duplicating the reported malfunction.The device's biphasic cable was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.Please refer to the attached user medwatch report that zoll medical has received.

Manufacturer Narrative

Additional information: inadvertently did not attach user medwatch report.

• 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: 8420085
• MDR Text Key: 138771656
• Report Number: 1220908-2019-00628
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00847946002916
• UDI-Public: 00847946002916
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/09/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 02/20/2019
• Distributor Facility Aware Date: 02/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2019
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• 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
• Patient Age: 39 YR
• Patient Weight: 83