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

Model Number X SERIES

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Necrosis (1971)

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 male patient (age unknown) in cardiac arrest, the device did not recognize that it was attached to a patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Zoll medical united kingdom evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, ecg monitoring stress testing, and analyzing functional stress testing without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs indicated that a patient impedance is never recognized.Electrodes are recognized as attached to the device, but not to a patient.There are many reasons why the device may not have detected a valid patient impedance, including but not limited to: pads not applied to patient pads are not fully inserted into the mfc (or cpr-d adapter) proper connection between pads and adapter faulty cpr-d adapter/mfc on the patient end faulty pads preventing proper connection faulty pads preventing identification.Analysis of reports of this type has not identified an increase in trend.The pads used at the time of the reported event were not returned for evaluation.

• Brand Name: X SERIES
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11164976
• MDR Text Key: 226640317
• Report Number: 1220908-2021-00106
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death