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

Model Number	X SERIES
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Electrocution (1827); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device would not deliver the discharge showing a "check pads" message.The medics attempted to reposition the pads to correct the message , the device then delivered the delayed discharge (due to error message) causing unintended energy to be delivered to the person repositioning the pads and the person performing cpr on the patient.Complainant indicated that there was no adverse effect to the patient or the two medics attending to the patient.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b1, b2, and h6 (patient code).Evaluation: the device was returned to zoll medical canada and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling and multiple shock tests without duplicating the report.An internal inspection and close examination of the front enclosure and the shock button found no discrepancies.The device was recertified and returned to the customer.Review of the device activity logs showed the device to be in a lead fault state when the shock button was pressed and would not deliver energy until the lead fault is resolved.Once the lead fault was resolved, the shock was delivered.There was no indication in the log of a device malfunction.No accessories were received with the device as part of this investigation.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10140105
• Report Number: 1220908-2020-01649
• Device Sequence Number: 2164103
• Product Code: MKJ
• UDI-Device Identifier: 00847946099541
• UDI-Public: 00847946099541
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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?: Yes
• Operator of Device: 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 Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other