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

Model Number	799-EGL2-00
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing including internal inspection, bench handling, calibration testing and functional stress testing without duplicating the report.The smart pneumatic board was replaced as a precaution.The device was recertified and returned to the customer.The patient circuit was not returned as part of this investigation.No trend is associated with reports of this type.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age and gender unknown) the device stopped ventilating.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 8836784
• Report Number: 1220908-2019-02090
• Device Sequence Number: 19518513
• Product Code: CBK
• UDI-Device Identifier: 00847946020675
• UDI-Public: 00847946020675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

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: Health Professional
• Device Model Number: 799-EGL2-00
• Device Catalogue Number: 799-ELG2-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1