MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR

Model Number	E SERIES
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during a routine shift check by a clinician, the device would intermittently not power up and inappropriately shut down.Complainant indicated that there was no patient involvement in the reported malfunction.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device's display showed horizontal lines and was not legible.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (device code).Evaluation: the device was returned to zoll medical corporation and the customer's report of "lines on video display" was observed upon initial testing.However, the report was not duplicated after reseating a system interconnection flex cable.The system interconnection flex cable was replaced as a precaution.The customer's report of "no power up and inappropriate shut down" was duplicated and attributed to a faulty switch on the control board.The control board was replaced.The device was recertified and returned to the customer.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: 10523554
• Report Number: 1220908-2020-02829
• Device Sequence Number: 16932832
• Product Code: MKJ
• UDI-Device Identifier: 00847946016029
• UDI-Public: 00847946016029
• 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): 08/23/2020

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: 09/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2020
• Supplement Date Received by Manufacturer: 08/23/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1