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

Model Number	799-EGB2-01-01
Medical Device Problem Codes	Disconnection (1171); Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during functional testing, the device would not build pressure.This is all the information available.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Event or Problem Description
Complainant alleged that during functional testing, the device displayed a "patient disconnect 2100" message.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional 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 problem code).Evaluation: the device was returned to zoll medical corporation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including complete calibration, internal inspection, and outgoing system tests without duplicating the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.Reports of this nature are typically not submitted as there would be no potential for clinical impact.

• Brand Name: UNI-VENT, MODEL 731
• Common Device Name: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 12240704
• Report Number: 1220908-2021-02362
• Device Sequence Number: 19750679
• Product Code: CBK
• UDI-Device Identifier: 00847946026592
• UDI-Public: 00847946026592
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K111473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Other
• Device Model Number: 799-EGB2-01-01
• Device Catalogue Number: 799-EGB2-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1