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

Model Number 799-EGB2-01-01

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2020

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 while attempting to treat a patient (age & gender unknown), the device failed the pre-pressure check.Complainant did not indicate that there was any adverse effect to the patient due to 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.

• Brand Name: UNI-VENT, MODEL 731
• Type of Device: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11457141
• MDR Text Key: 239106762
• Report Number: 1220908-2021-00674
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00847946026592
• UDI-Public: 00847946026592
• Combination Product (y/n): N
• PMA/PMN Number: K111473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 799-EGB2-01-01
• Device Catalogue Number: 799-EGB2-01-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1