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

Model Number X SERIES

Device Problem Fire (1245)

Patient Problems Burn(s) (1757); Necrosis (1971)

Event Date 08/28/2021

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 defibrillate a (b)(6) year-old male patient, the device delivered two shocks.Upon the third shock a fire occured causing burns to the patient's face and neck.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Zoll medical united kingdom evaluated the device and the device performed to specification.The device was recertified and returned to the customer.The electrode pads were not returned for evaluation.The x series operator's guide states: do not use the x series in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).Using the unit in such environments might cause an explosion.Proper patient preparation to maximize skin coupling between the electrodes and patient are recommended to minimize the possibility of a spark causing ignition.The device was used in such an environment and a fire occurred.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: 12491946
• MDR Text Key: 272020959
• Report Number: 1220908-2021-03124
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 10/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR