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

Model Number 799-EMVP-05-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 330721932
• Report Number: 1220908-2023-04841
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00847946023430
• UDI-Public: 00847946023430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 11/27/2023; Not provided
• Supplement Dates FDA Received: 01/15/2024; 06/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male