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)
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 monitoring a patient (age & gender unknown) during transport in an ambulance, the device inappropriately shut down.Complainant indicated that the clinician plugged the device to the inverter in the ambulance to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not observed with the device.The device was put through extensive testing which included bench handling and stress testing without duplicating the malfunction.The device's high voltage battery pins were replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• 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: 8137513
• Report Number: 1220908-2018-03509
• Device Sequence Number: 13502520
• Product Code: MKJ
• UDI-Device Identifier: 00847946015671
• UDI-Public: 00847946015671
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K042007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 11/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1