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

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem Death (1802)

Event Type  Death  

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 patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was returned to zoll medical (b)(4).The device was subjected to full functional testing and ecg testing with no discrepancies found.The device was observed to be functioning as expected.The device was recertified and returned to the customer.Review of the device activity logs for the case in question indicated that the device recognized a patient impedance.However; the ecg signal was not being displayed on the monitor display because the device was left in lead ii view.The end user would need to change the lead view to the pads view in order to obtain the ecg signal from the patient onto the monitor display.The lead can be changed by pressing the lead button, or entering one of the defib modes such as; analyze, energy select, charge or shock.There was no evidence of a device malfunction and the device meet specifications.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: 9488733
• MDR Text Key: 171811629
• Report Number: 1220908-2019-04008
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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: 12/09/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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 Outcome(s): Death