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

Model Number	AED PRO
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
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 failed to discharge.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 section b5 and h6 (device problem code).Evaluation: the device was returned to zoll medical corporation without the battery used at the time of the event for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating any malfunction that would have depleted the battery pre-maturely.The device was recertified and returned to the customer.Contact with the customer suggests the device was not maintained as recommended.A review of the logs confirm the device was deployed without electrode pads attached on several occasions for an unknown amount of time.This will cause the device to be in a red x state until pads are attached.Analysis of reports of this type has not identified an increase in trend.Reports of this nature are not considered to meet our requirements for submission of a medwatch report.All indications suggest the device was capable of delivering therapy.
Event or Problem Description
Complainant alleged that while preparing to treat a patient (age & gender unknown), the device prompted a "change battery" message.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: 16043063
• Report Number: 1220908-2022-05009
• Device Sequence Number: 14676634
• Product Code: MKJ
• UDI-Device Identifier: 00847946016135
• UDI-Public: 00847946016135
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/05/2022

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: AED PRO
• Device Catalogue Number: AED PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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
• Patient Sex: Unknown