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

Model Number MSERIES BI-PHASIC

Device Problems Device Operational Issue (2914); Improper Alarm (2951)

Patient Problem No Information (3190)

Event Type  Injury  

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 treat a patient (age & gender unknown), the device did not operate correctly.Complainant indicated that the patient subsequently sustained an injury.No further information was available.

Manufacturer Narrative

This follow up medwatch report is reporting the evaluation of the device.This follow up medwatch report is also correcting information submitted on the initial medwatch report.The customer was contacted for return of the suspect product.The customer has responded and indicated that they will not be returning the device to zoll for evaluation.A zoll medical representative evaluated the device in a limited capacity at the customer's facility.The device passed testing and no discrepancies were noted.The customer has indicated that the device has been taken out of service.No trend has been identified.

Event Description

Complainant alleged that while attempting to treat a male patient (age unknown), the device displayed a "check pads" message.Complainant indicated that the clinician obtained another device to no avail.Complainant indicated that the patient subsequently sustained an injury.

• 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: 7061316
• MDR Text Key: 93002928
• Report Number: 1220908-2017-02995
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946013691
• UDI-Public: 00847946013691
• 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
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2003
• 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): Other