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

Model Number 799-EMVP-04-01

Device Problems Use of Device Problem (1670); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

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 male patient (age unknown), the device displayed an unknown error message.Complainant did not indicate that there was any 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.Please reference section b5 and h6 (device code).Evaluation: the device was returned to zoll medical corporation; the customer's report was duplicated and attributed to disconnected tubing.The tubing was reconnected to resolve the report.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to treat a male patient (age unknown), the device displayed a "patient disconnect - 2100" message.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• 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: 11422601
• MDR Text Key: 234971133
• Report Number: 1220908-2021-00582
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00847946023423
• UDI-Public: 00847946023423
• Combination Product (y/n): N
• PMA/PMN Number: K111473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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-04-01
• Device Catalogue Number: 799-EMVP-04-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1