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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device was unable to obtain an ecg signal via 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 corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.Review of the device data logs showed that the user was in the incorrect "lead view" while electrode pads were being used.While using electrode pads, the "pads view" should be used.The user would need to switch lead selection to the "pads" to obtain the ecg signal view with the electrode pads attached to the patient.The customer would have seen an ecg in the lead that was on the device at the time of the event if an ecg cable was attached to the device and connected to the patient.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 14436594
• Report Number: 1220908-2022-01768
• Device Sequence Number: 14847559
• Product Code: MKJ
• UDI-Device Identifier: 00847946020491
• UDI-Public: 00847946020491
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 05/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown