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

Model Number	20000000100011360
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2024
Type of Reportable Event	Death
Event or Problem Description
Complainant alleged that while attempting to treat a 60/70-year-old female patient, the device prompted a change batteries message.The user thought this meant the device was not operational and did not try to use the device following the change batteries prompt.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The device was returned to zoll medical japan for evaluation.The customer's report was verified during evaluation.A review of the device log shows the device was notifying a red x condition beginning 10 months prior to the device being deployed on a patient that was not addressed.The device was tested with the customer's returned batteries and was able to power on and pass the device battery installation test and battery test.The user at the time of the event was a lay-user and did not know the device would still operate despite prompting a "change batteries" message.Root cause is related to following zoll reommendations for operational readiness.The aed plus administrator's guide, 9650-0301-28 recommends that the device be visually inspected often, as necessary, to ensure that the device is displaying a green check and is rescue ready.The administrator's guide also states that, if the unit prompts "change batteries" a low battery condition has been detected and the batteries must be replaced immediately.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PLUS
• 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: 21091575
• Report Number: 1220908-2024-04800
• Device Sequence Number: 9171791
• Product Code: MKJ
• UDI-Device Identifier: 04560233596016
• UDI-Public: (01)04560233596016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: 20000000100011360
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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 Sex: Female