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

Model Number	E SERIES
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode = dro.Zoll medical corporation evaluated the device and the reported malfunction was observed but not duplicated.The device was put through extensive testing without duplicating the malfunction.The device's system board frame, connector interlock, and a system interconnection flex cable were replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device displayed "defib fault 72" and "pacer fault 116" messages.Complainant indicated that there was no patient involvement in the reported malfunction.

• 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: 6795590
• Report Number: 1220908-2017-01922
• Device Sequence Number: 13485837
• Product Code: MKJ
• UDI-Device Identifier: 00847946011420
• UDI-Public: 00847946011420
• 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
• Report Date (Section B): 07/28/2017

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: Health Professional
• Device Model Number: E SERIES
• Device Catalogue Number: E SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1