MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR

Model Number	E SERIES
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the device failed self test for defib function.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation; however, a zoll representative observed the reported malfunction at the customer site.The customer was contacted for the return of the device to zoll for evaluation.The customer indicated that they are retiring the device.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; a zoll representative observed the reported malfunction at the customer site.However, the reported malfunction was not replicated or confirmed at zoll.The device was subjected to functional testing, shock testing, and bench handling with no faults found.Review of the device logs did not find evidence to support the reported event.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: 8193886
• Report Number: 1220908-2018-03721
• Device Sequence Number: 11259423
• Product Code: MKJ
• UDI-Device Identifier: 00847946008871
• UDI-Public: 00847946008871
• 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,Followup
• Report Date (Section B): 12/04/2018

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: 03/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 12/04/2018
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 01/29/2019; 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1