MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR

Model Number	E SERIES
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/05/2020
Type of Reportable Event	Death
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 displayed a "defib pad short" message and failed to discharge.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.Please reference medwatch report number 1220908-2020-00808 for a report from the same customer.
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 results: the device and accessories were not returned to zoll for evaluation.A picture of the error log was provided for review.The customer's report was observed during review of the provided picture.The message seen occurs when the device detects a defib impedance lower that 15 ohms while the shock button is pressed with an energy setting not equal to 30j.Under these conditions the device will not deliver a shock other than 30j.Without receiving the device for investigation, root cause could not be firmly established.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: 9891593
• Report Number: 1220908-2020-00931
• Device Sequence Number: 13994307
• Product Code: MKJ
• UDI-Device Identifier: 00847946011123
• UDI-Public: 00847946011123
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/06/2020

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: E SERIES
• Device Catalogue Number: E SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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: Death