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

Model Number	X SERIES
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: dro.Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a (b)(6) male patient during cardiac arrest, after one successful shock, the patient was noted to be in ventricular tachycardia and on the attempt to shock the device displayed a "defib/pacer failure" message.The device was re-started in an attempt to clear the message and the device failed the power on self-test for defib and pacer functions.Complainant indicated that the clinician obtained another device to continue treating the patient.However the rhythm returned to pulseless electrical activity.Complainant indicated that due to the patient current clinical status the patient's family discontinued efforts to resuscitate and the patient was transitioned to comfort measure only.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The reported malfunction was observed during review of the device's activity logs.However, the device was put through extensive testing which included environmental and functional testing without duplicating the malfunction.The device was replaced for the customer as an accommodation.It's important to mention that the pads used during the time of the event was not returned for evaluation as part of the investigation.Analysis for 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: 7843533
• Report Number: 1220908-2018-02501
• Device Sequence Number: 13760375
• Product Code: MKJ
• UDI-Device Identifier: 00847946018238
• UDI-Public: 00847946018238
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR