MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR

Model Number	E SERIES
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age and gender unknown), the device was unable to power on and would intermittently power on.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Complainant indicated that during subsequent biomed testing, the malfunction was duplicated intermittently.
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 environmental and functional testing without duplicating the reported malfunction.It is noteworthy to mention the battery used at the time of the customer's report was not returned for evaluation.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• 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: 6452822
• Report Number: 1220908-2017-00688
• Device Sequence Number: 19051299
• Product Code: MKJ
• UDI-Device Identifier: 00847946010492
• UDI-Public: 00847946010492
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2017

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: 03/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1