MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL AEV (TAN, COMMERCIAL); VENTILATOR

Model Number	799-AEV1-00-01
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670); Calibration Problem (2890); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during functional testing, the device displayed an unknown error.This is all the information available.Complainant did not indicate that there was any patient involvement in 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 (medical device problem code) updated.The device was returned to zoll medical corporation for evaluation.The customer reported that a failure alarm occurred upon power-up.Log review identified multiple self-check failure 1001 alarms between (b)(6) 2025 and (b)(6) 2025, occurring at power-up and clearing shortly thereafter.This alarm can occur if the device is powered on with the red dust cap installed on the patient output port.The facility confirmed awareness that the red cap must be removed prior to power up, and the log behavior indicates the cap was removed after the alarm occurred, allowing the alarm to clear.Upon receipt, with the red cap removed, the device did not reproduce the 1001 alarm.This report will be closed as device meet specification.A runtime calibration failure 1051 was observed during evaluation and was determined to be caused by a faulty smart pneumatic module (spm) board.The spm board was replaced to remedy the report.The board was scrapped after testing.Review of the device logs also identified self-check failure 1052, which was related to the 1051 condition.This alarm was not independently reproduced during evaluation; therefore, the investigation for the 1052 alarm was closed as observed in device data.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during functional testing, the device displayed compressor failure 1001, airway pressure sensing failure 1052, and runtime calibration failure 1051 error messages.Complainant did not indicate that there was any patient involvement in the reported malfunction.

• Brand Name: MODEL AEV (TAN, COMMERCIAL)
• Common Device Name: VENTILATOR
• 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: 23285146
• Report Number: 1220908-2025-03747
• Device Sequence Number: 12142425
• Product Code: CBK
• UDI-Device Identifier: 00847946023461
• UDI-Public: (01)00847946023461
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K162832
• 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): 09/23/2025

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: 799-AEV1-00-01
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2017
• 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