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

Model Number	90010400499991010
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Unable to Obtain Readings (1516); Failure to Analyze Signal (1539); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code: 4019.Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a male patient (age unknown), the device (x series s/n (b)(6)) was unable to detect the attached electrode pads and failed to discharge.Complainant indicated that the clinician obtained another device (aed pro s/n (b)(6)) to continue treating the patient and the device prompted a ?unit failed? message, shutdown and would not power up.Paramedics arrived with a third device, shocked the patient and obtained rosc.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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 sections b5, h6 (medical device problem code), d4 model # updated, d4 catalog # removed, d4 primary udi # updated.Evaluation results: the device and disposable battery were returned to zoll medical canada for evaluation.The customer's report related to "device is unable to discharge" is attributed to the cpr adaptor.The cpr adaptor was scrapped after testing.The customer's report related to the same battery could not turn on the device was verified and attributed to a depleted battery.The customer's report related to the unit advised non-shockable on what appears to be a shockable rhythm was confirmed as the device meets specification.Review of the clinical data indicates cpr interference was the main cause of the non-shockable decision.The device was recertified and returned to the customer.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a male patient (age unknown), the device (x series s/n (b)(6) was unable to analyze and failed to discharge.Complainant indicated that the clinician obtained another device (aed pro s/n (b)(6) to continue treating the patient and the device prompted a "unit failed" message, shutdown and would not power up.Paramedics arrived with a third device, shocked the patient and obtained rosc.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 19475586
• Report Number: 1220908-2024-02017
• Device Sequence Number: 17910482
• Product Code: MKJ
• UDI-Device Identifier: 00847946016142
• UDI-Public: (01)00847946016142(21)AA16C039068
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 90010400499991010
• Device Catalogue Number: AED PRO
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: X SERIES SN (B)(6).
• Patient Sex: Male