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

Model Number	X 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
(b)(4).Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device displayed a "pace defib device failure" message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The processor/bridge/pace board was replaced as a precaution.The device was recertified and returned to the customer.The activity log was cleared by the customer and could add no value to the investigation.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6569291
• Report Number: 1220908-2017-01070
• Device Sequence Number: 1170265
• Product Code: MKJ
• UDI-Device Identifier: 00847946018115
• UDI-Public: 00847946018115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112432
• 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
• Report Date (Section B): 04/26/2017

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: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1