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 Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported malfunction was observed during review of the device history logs.However, the device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs showed that there was an ecg signal in leads, followed by multi-lead faults that are not resolved for the remainder of the case.The logs show that electrode pads on message indicating therapy pads are applied to the patient.However, the user remains in lead ii and therefore does not see an ecg signal on the display.The user would need to change the lead view to pads view to view the ecg signal on the display.Based on the pads impedance chart, we expect the pads view would have displayed a good ecg signal if the user changed ecg view.Analysis of reports of this type has not identified an increase in trend.
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 indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8345805
• Report Number: 1220908-2019-00464
• Device Sequence Number: 1959746
• Product Code: DRT
• UDI-Device Identifier: 00847946006389
• UDI-Public: 00847946006389
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1