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

Model Number	799-AEV1-01
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
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 while attempting to treat a patient (age & gender unknown), the device displayed an "power on self test failure - 1084" error message.Complainant indicated that the clinician bag mask ventilated to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report 1220908-2018-03482 for a similar event reported from the first device used on the same patient.
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 bench handling, extensive stress testing, functional testing and a full internal inspection without duplicating the report.The autocal valve was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: UNI-VENT MODEL AEV
• Common Device Name: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8119226
• Report Number: 1220908-2018-03450
• Device Sequence Number: 16558334
• Product Code: CBK
• UDI-Device Identifier: 00847946020651
• UDI-Public: 00847946020651
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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-AEV1-01
• Device Catalogue Number: 799-AEV1-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1