MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL EMV+, COMM, MRI; VENTILATOR

Model Number	799-EMVP-05-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a 32-year-old male patient, the device displayed an "internal comm failure -1474" message.Complainant indicated that the clinician power cycled the device and continued use for the rest of the flight.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.Evaluation: the device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the forensic memory log.However, the device was put through extensive testing without duplicating the report.An internal inspection found the ferrite tube loose but we could not link this to the customer report.The ribbon cable was replaced and the ferrite tube was properly secured as a precaution.The device was recertified and returned to zoll medical corporation's loaner device inventory.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
This supplemental medwatch report updates information based upon your request which differs from the initial medwatch report filed.Please reference updated section d1 brand name and section d4 catalog number that does not apply and should be removed.

• Brand Name: MODEL EMV+, COMM, MRI
• 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: 18344745
• Report Number: 1220908-2023-04841
• Device Sequence Number: 6222416
• Product Code: CBK
• UDI-Device Identifier: 00847946023430
• UDI-Public: 00847946023430
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111473
• 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,Followup
• Report Date (Section B): 11/27/2023

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-EMVP-05-01
• Device Catalogue Number: 799-EMVP-05-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• 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: 11/27/2023; Not provided
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/15/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2017
• 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 Age: 32 YR
• Patient Sex: Male