MAUDE Adverse Event Report: ZOLL Medical Corporation LTV 2200 VENTILATOR

Model Number	22690-001
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's report was observed during testing, however, the device was put through extensive testing without duplicating the report.The analog board was replaced as a precaution.G1: contact information was updated.
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 the device is over triggering with a "check circuit " alarm message.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Technical support recommended that the analog board be replaced to resolve the reported malfunction.The analog board that was removed from the device was returned to the failure analysis lab for evaluation.During evaluation, the reported malfunction was unable to be duplicated.

• Brand Name: LTV 2200 VENTILATOR
• Common Device Name: VENTILATOR
• Manufacturer (Section D): ZOLL Medical Corporation; 26125 n. riverwoods blvd; chelmsford MA 01824
• Manufacturer Contact: anne nadeau ; 1100 bird center drive; palm springs, CA 92262 ; +1(351)500-4978
• MDR Report Key: 21678934
• Report Number: 3013421741-2025-01510
• Device Sequence Number: 7693281
• Product Code: CBK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2025

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: 22690-001
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/05/2025; 03/12/2026; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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