MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR

Model Number	E SERIES
Medical Device Problem Codes	Loss of Power (1475); Failure to Power Up (1476)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/01/2017
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 female patient (age unknown), the device would restart/reboot itself.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional 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: the device was returned to zoll medical corporation for evaluation and the customer's report was not duplicated under testing with a test battery.Review of the device activity log did show activity consistent with the customer's report.The battery pins were replaced as a precaution.It is noteworthy to mention the non zoll battery used at the time of the reported event was not returned for evaluation.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while monitoring a female patient (age unknown), the device would intermittently power off and on.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 6968475
• Report Number: 1220908-2017-02610
• Device Sequence Number: 11035746
• Product Code: MKJ
• UDI-Device Identifier: 00847946015466
• UDI-Public: 00847946015466
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/02/2017

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: 10/06/2017
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1