MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR

Model Number	E SERIES
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
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 monitoring a patient (age and gender unknown), the device was unable to detect the attached electrode pads.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.Device evaluation: the device was not returned to zoll medical corporation; follow up with the customer found that the incorrect leads view was selected by the end user.It was confirmed by the customer that the device operated as intended.Reports related to ecg monitoring leads typically do not meet zoll's requirements for a reportable submission.
Event or Problem Description
Complainant alleged that while monitoring a patient (age & gender unknown), the device displayed a "lead off" message 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: 7025303
• Report Number: 1220908-2017-02835
• Device Sequence Number: 940060
• Product Code: MKJ
• UDI-Device Identifier: 00847946009137
• UDI-Public: 00847946009137
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1