MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR

Model Number	E SERIES
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown) in cardiac arrest, the device inappropriately shut down.Complainant indicated that the clinician plugged the device into ac to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report 1220908-2018-03771 for a similar event reported from the same customer.
Additional 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 vigorous bench handling without duplicating the malfunction using test batteries.The device's system to battery cable connector interlock, system interconnect cable, and battery pwr/gnd pin were replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.Review of the error logs did not find evidence to support the reported event.

• Brand Name: E SERIES DEFIBRILLATOR
• Common Device Name: E SERIES
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8209063
• Report Number: 1220908-2018-03806
• Device Sequence Number: 13870548
• Product Code: MKJ
• UDI-Device Identifier: 00847946015435
• UDI-Public: 00847946015435
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042007
• 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): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: E SERIES
• Device Catalogue Number: E SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1