MAUDE Adverse Event Report: PNEUPAC; VENTILATOR

Model Number	130003V
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smith medical ventilators|pneupac ventilators ventipac malfunctioned.Reported air is leaking and gauge is off.Inspiratory knob is catching on something.Event occurred during testing and no patient involvement.

• Brand Name: PNEUPAC
• Common Device Name: VENTILATOR
• MDR Report Key: 12262416
• Report Number: 3012307300-2021-07950
• Device Sequence Number: 11885977
• Product Code: BTL
• UDI-Device Identifier: 35019315074183
• UDI-Public: 35019315074183
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K030803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2021

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: No Information
• Device Model Number: 130003V
• Device Catalogue Number: 130003V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 08/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1