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

Model Number	X SERIES
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Information (3190)
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 defibrillate a patient (age and gender unknown), the associated defibrillator was unable to detect the attached electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical canada evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the reported malfunction.Review of the clinical data shows the device was always in lead ii.The logs indicate the device was powered on multiple times which the device did detect the electrode pads, with the exception of the last power up.The device recognized the electrode pads as unsupported cable/electrode.It is important to mention the multi-function cable and cpr adapter were not returned for evaluation.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: 7215451
• Report Number: 1220908-2018-00147
• Device Sequence Number: 10804110
• 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): 01/05/2018

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1