MAUDE Adverse Event Report: PNEUPAC; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE

Model Number	100/905/340-CH
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that the airway pressure meter was not working when the pneupac disposable circuit was connected to the ventilator.This product problem was observed during a pre-test.No patient injury or complications were reported in relation to this event.
Event or Problem Description
Device evaluation completed and summary in h 10.
Additional Manufacturer Narrative
Other, other text: investigation completed on a smiths medical ventilators|pneupac disposable circuits.The report of during precheck the customer noticed no anomaly in unit but after hooking up to ventilator pressure meter did not work.Functional testing was done and found no issue with device.The complaint was not verified.

• Brand Name: PNEUPAC
• Common Device Name: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE
• MDR Report Key: 11494953
• Report Number: 3012307300-2021-02103
• Device Sequence Number: 19723940
• Product Code: BTL
• UDI-Device Identifier: 15019517160215
• UDI-Public: 15019517160215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021
• 2 Devices were Involved in the Event: 1 2

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: 100/905/340-CH
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 200521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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