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

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problems Necrosis (1971); No Information (3190)

Event Date 12/13/2020

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 monitor a patient (age & gender unknown), the device displayed a "check pads" message.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Event Description

Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device displayed a "lead fault" message.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Evaluation results: the device was returned to zoll medical united kingdom.The customer's report was not replicated or confirmed.Review of the device log shows that ecg leads were connected at the beginning of the case and the device defaulted to auto ecg lead view since pads were not yet attached to the patient.Once pads were applied, the user did not switch the ecg view to pads resulting in the device remaining in lead view.There is also evidence that a patient impedance was acquired and an ecg signal would have been seen had the ecg view been switched to pads.The device passed full functional testing including ecg testing using the returned multifunction cable without duplicating the report.The device was recertified and returned to the customer.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
• MDR Report Key: 11097657
• MDR Text Key: 224522221
• Report Number: 1220908-2020-04332
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death