MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR

Model Number	E SERIES
Medical Device Problem Codes	Failure to Power Up (1476); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during a routine shift check by a clinician, the device displayed an unknown error message and was unable to power on fully.No further information was available.Complainant indicated that there was no patient involvement in the reported malfunction.Please reference medwatch reports 1220908-2018-00180, 1220908-2018-00185, 1220908-2018-00187, 1220908-2018-00188, 1220908-2018-00109 for similar events reported from the same customer.
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.
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 reported malfunction was observed and attributed to the lithium battery on the system board.Zoll medical corporation recommends replacement of the lithium battery on the system board every 5 years.This device is approximately 12 years old from date of manufacture.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device was unable to power on fully.No further information was available.Complainant indicated that there was no patient involvement in the reported malfunction.Please reference medwatch reports 1220908-2018-00180, 1220908-2018-00185, 1220908-2018-00187, 1220908-2018-00188, 1220908-2018-00109 for similar events reported from the same customer.

• 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: 7228379
• Report Number: 1220908-2018-00138
• Device Sequence Number: 11052377
• Product Code: MKJ
• UDI-Device Identifier: 00847946015640
• UDI-Public: 00847946015640
• 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,Followup
• Report Date (Section B): 01/09/2018

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: 04/26/2018
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/09/2018; 01/09/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 02/21/2018; 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1