MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION UNI-VENT, MODEL 731; VENTILATOR

Model Number 799-EGB2-00-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

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 patient (age & gender unknown), the device displayed "internal comm failure-1471" and "internal communication failure-3470" error messages.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation and the customer report was observed in the forensic memory log.However, the device was put through extensive testing with a known good test setup without duplicating the report.No damage was observed due to the use of the vent in the hyperbaric chamber.The device was recertified and returned to the customer.It is noteworthy to mention; the z vent operator's contains the warning: the device is not intended for hyperbaric operation.Use in a hyperbaric chamber can result in harm to the patient and/or damage to the device.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: UNI-VENT, MODEL 731
• 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: 19200671
• MDR Text Key: 341248098
• Report Number: 1220908-2024-01468
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00847946024208
• UDI-Public: 00847946024208
• 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
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 799-EGB2-00-01
• Device Catalogue Number: 799-EGB2-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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