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

Model Number	X SERIES
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	05/26/2021
Type of Reportable Event	Death
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 monitor a patient (age & gender unknown), the device was unable to analyze.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
Additional Manufacturer Narrative
The device was received at zoll medical corporation and the customer's report was unsubstantiated.Review of the device log shows evidence that the device successfully analyzed 4 times in response to analyze button presses.The first resulted in a shock advised, and the remaining three resulted in no shock advised.During the only shock advised prompt, energy was not delivered.The device passed all testing 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
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 12020642
• Report Number: 1220908-2021-01899
• Device Sequence Number: 16991311
• Product Code: MKJ
• UDI-Device Identifier: 00847946005849
• UDI-Public: 00847946005849
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 05/27/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 05/27/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/26/2021; 09/24/2021
• 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: Death