MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number	E SERIES
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
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 while attempting to treat a (b)(6) year old female patient, the device would not power up.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The reported malfunction was observed and attributed to a faulty battery.The battery would not charge and indicated errors consistent with the battery current below the specified range.The battery was replaced.Additional information received from the customer during the investigation indicated that this device is kept on the ambulance plugged into the auxiliary power with the battery remaining in the device while it is not in use.Zoll suggests that customer's have a sufficient number of battery packs and chargers to ensure adequate supply of fully charged primary and spare use battery's.It is also suggested that batteries be rotated to a schedule based on usage and periodic deep cycling.The battery involved in the reported event was manufactured at the end of 2015 and determined to be approximately 36 months old.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: E SERIES DEFIBRILLATOR
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7694152
• Report Number: 1220908-2018-01978
• Device Sequence Number: 19221067
• Product Code: MKJ
• UDI-Device Identifier: 00847946009175
• UDI-Public: 00847946009175
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/26/2018

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: 07/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1