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

Model Number 799-EGL2-00-01

Device Problem Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

Complainant alleged that during a routine shift check by a clinician, the device displayed "internal comm failure-3470" and "internal comm failure-1471" error messages.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's reports were observed during review of the device data log.The device was put through extensive testing including stress testing and troubleshoot testing without duplicating the report.The main li-ion battery and ribbon cable were replaced as a precaution.The device was recertified and returned to customer.Analysis of reports of this type has not identified an increase in trend.

Manufacturer Narrative

This supplemental medwatch report updates information submitted in the previous medwatch report.Adding justification per your request for the reason why d4 primary udi was no_udi.The device reported was manufactured and distributed for domestic sales before the enforcement date of udi-di.This is applicable only if the device is not labeled.

• 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: 17871171
• MDR Text Key: 324927212
• Report Number: 1220908-2023-03857
• 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
• Report Date: 09/15/2023

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-EGL2-00-01
• Device Catalogue Number: 799-EGL2-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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