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

Model Number	X SERIES
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown) during transport, the device was unable to obtain an ecg signal after the therapy cable was unplugged and plugged back into the device.Complainant indicated that the clinician obtained another device and associated electrode pads to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.Complainant indicated that during subsequent functional testing, the malfunction was not duplicated.
Additional Manufacturer Narrative
Zoll medical (b)(4) evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Review of the device history log provided evidence of the customer's report.The device's multi-function cable connector was replaced as a precaution.The device was recertified and returned to the customer.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: 7139265
• Report Number: 1220908-2017-03238
• Device Sequence Number: 1069644
• Product Code: MKJ
• UDI-Device Identifier: 00847946012649
• UDI-Public: 00847946012649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1