MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATORS BABY PAC; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	150003
Medical Device Problem Codes	Unable to Obtain Readings (1516); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator o2 gas supply indicator was sticky and not working properly and the cap was bent.No report of patient involvement.
Additional Manufacturer Narrative
Date of event is unknown, no information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: d3, g1, and g2 email is: (b)(4).Device evaluation: one device was returned for investigation in used condition without original packaging.The valve assembly was bent and front panel is slightly bowed between the gas supply indicator and manometer.Functional testing was done where the customer complaint was confirmed.The gas supply indicator did not change from red to white with gas supply.The gas supply tubing was stuck underneath the main board and the housing.This can only happen from shifting or removal of the front panel.Impact caused a bent patient valve set.Maintenance was done and device passed all functionality tests.Root cause most probably traced to impact and user interface issues.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Installed mri battery, sintered filters, and o-rings for the preventative maintenance (pm).Re-shaped front panel.Adjusted peep/ cpap control and peak inspiratory control to tolerance.Performed pm, cleaned unit and affixed new service label.

• Brand Name: PNEUPAC VENTILATORS BABY PAC
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16752974
• Report Number: 3012307300-2023-04203
• Device Sequence Number: 11604443
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970158
• 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): 12/07/2023

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: 150003
• Device Catalogue Number: 150003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2009
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown