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	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device 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), 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 did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation.Instead, the data file from the event was received.Review of the data file showed messages indicating a loss of ecg signal.However, without receipt of the device, cable, and adapter a root cause cannot be established.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.Instead, a multifunction cable and cpr adapter were provided.The reported malfunction was not replicated.The multifunction cable and cpr adaptor were put through extensive testing including functional testing using a test device without duplicating a malfunction.Continuity testing and visual inspection found no discrepancies.The multifunction cable and cpr adaptor were scrapped.Review of the data log identified typical user advisories related to loss of the ecg signal.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
• MDR Report Key: 10260538
• Report Number: 1220908-2020-02030
• Device Sequence Number: 11017993
• Product Code: MKJ
• 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,Followup,Followup
• Report Date (Section B): 06/19/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 06/19/2020; 06/19/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/29/2020; 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1