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

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem Cardiac Arrest (1762)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to treat a (b)(6) male patient in cardiac arrest, the device was unable to obtain an ecg signal via electrode pads.The clinician obtained another set of electrode pads, another x series device sn (b)(4) and was unable to obtain an ecg signal.Complainant indicated that the clinician obtained a third device to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation evaluated the two devices involved in this event and the device's performed to specification.The device's were recertified and returned to the customer.Review of the clinical data files for each device did show a poor ecg signal via electrode pads.The patient impedance was fluctuating in conjunction with multiple occurrences of pads on, pads off messages.This may indicate poor coupling between the electrode pads and the patient's skin.The first set of electrodes used were returned and passed testing with no discrepancies found.Additional log review also showed that cpr was being performed throughout the case and even when cpr is not being performed the signal is poor.There were no error messages in either device log related to a device malfunction.This report has been attributed to poor coupling of the electrode pads to the patient's skin.The second set of electrode pads used was not returned as part of this investigation.Analysis of reports of this type has not identified an increase in trend.

• 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: 7238167
• MDR Text Key: 98973611
• Report Number: 1220908-2018-00145
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00847946004378
• UDI-Public: 00847946004378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: 20 YR