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

Model Number	X SERIES
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleged that while defibrillating a (b)(6) -year-old male patient, after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient sustained third degree burns.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The electrode pads used were not returned to zoll medical corporation for evaluation.The clinical logs were not available and no pictures of the reported burns were provided.After further review of the facts provided by the customer, it was deteremined that the device was being used incorrectly by the user.The customer's report stated that the patient was burned after an extended period of pacing the patient (19 hours) using onestep complete electrode pads.According to the onestep cpr complete instructions for use, non-invasive temporary pacing information states: onestep pacing is function with r series only and is intended for emergency pacing only.Electrodes should be replaced after 24 hours of use or 8 hours of pacing to maximize patient benefit.Trnscutaneous pacing longer than 30 minutes may cause burns to the skin.Burns occurring during pacing are an anticipated outcome and are anticipated to occur if electrodes are used outside of the ifu recommendations.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: 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: 12928333
• Report Number: 1220908-2021-04207
• Device Sequence Number: 5020418
• Product Code: MKJ
• UDI-Device Identifier: 00847946017019
• UDI-Public: 00847946017019
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male