MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PRO; DEFIBRILLATOR

Model Number	90010400499991010
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	02/26/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a 64 -year-old male patient, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.A review of the clinical log for the reported event date observed the first analysis event had two of the three segments not match any of the algorithmic definitions for shockable or non-shockable rhythms.Both segments had noise that could have been caused by motion which may have affected the analysis results.Since two of the three segments were determined to be not shockable, the overall result was no shock advised.The aed worked as designed and within the limitations of the technology.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: AED PRO
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 19728806
• Report Number: 1220908-2024-02487
• Device Sequence Number: 20880686
• Product Code: MKJ
• UDI-Device Identifier: 00847946016142
• UDI-Public: (01)00847946016142
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• 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): 06/21/2024

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: 90010400499991010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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: Death
• Patient Age: 64 YR
• Patient Sex: Male