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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that during a routine shift check by a clinician, the device displayed an "internal comm failure- 1472" error message.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.

Manufacturer Narrative

A zoll field service representative went on site to evaluated the device.The customer's report was not replicated or confirmed.The device was put through extensive testing including stress testing without duplicating the report.An internal inspection resulted in no findings.The device was recertified for clinical use.The device logs from the time of the event are not available.No trend is associated with reports of this type.

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: 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: 18099781
• MDR Text Key: 327705224
• Report Number: 1220908-2023-04289
• Device Sequence Number: 1
• Product Code: CBK
• 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: 10/20/2023

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-EGB2-00-01
• Device Catalogue Number: 799-EGB2-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 10/20/2023; Not provided
• Supplement Dates FDA Received: 12/20/2023; 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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