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

Model Number X SERIES

Device Problems No Audible Alarm (1019); Incorrect Interpretation of Signal (1543)

Patient Problem No Information (3190)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to treat a (b)(6) male patient, the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the device was not returned to zoll medical corporation for evaluation.Instead, the device activity log was returned.Review of the log did show that the device prompted a "shock advised" message.However, we were unable to determine if the device prompted to "stand clear" using the log.The "stop cpr" prompt was not issued prior to the shock advised analysis start since the device was not in a cpr cycle.The prior analysis resulted in a "check pads" due to being in a pads off state for 1 minute and 8 seconds.This does not indicate a device malfunction.The data file does not have the capability to determine if the device gave the "stand clear" prompt.Based on review of the log, there was no indication of device malfunction.This report was inadvertently submitted and reports of this nature typically do not meet zoll's reportability requirements.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to treat a (b)(6) year- old male patient, the device did not issued a "stand clear" audio voice prompt.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• Brand Name: X SERIES
• Type of Device: 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: 8439660
• MDR Text Key: 139434810
• Report Number: 1220908-2019-00662
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

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
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 75 YR