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

Model Number	MSERIES BI-PHASIC
Medical Device Problem Codes	Device Operational Issue (2914); Improper Alarm (2951)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7061316
• Report Number: 1220908-2017-02995
• Device Sequence Number: 16480162
• Product Code: MKJ
• UDI-Device Identifier: 00847946013691
• UDI-Public: 00847946013691
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K990762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: MSERIES BI-PHASIC
• Device Catalogue Number: M SERIES
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other