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

Model Number	150003
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the ventilator unit was leaking.Patient involvement in unknown.
Additional Manufacturer Narrative
Device evaluated by manufacturer and h6.Evaluation codes: g2 email is: (b)(4).One device was received.Per visual inspection, the device was bowing on the left side of the manometer and the screw cover bung was punctured.Per functional testing, a leak was verified when air was applied to the device from the input block.The complaint was confirmed.The root cause was the input block.It was unknown what caused the condition.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.Replaced input block assembly, installed mri battery, sintered filters and o-rings.Re-shaped front panel and cleaned dirty valve diaphragm.Adjusted relief alarm pressure control, peak inspiratory control, "tins and texp" controls to tolerance.Performed preventative maintenance (pm), recalibrated unit, cleaned and affixed new service label.The device passed all functional and delivery tests.
Event or Problem Description
Additional information received via email.The customer responded the information requested was not available.

• 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: 16820013
• Report Number: 3012307300-2023-04619
• Device Sequence Number: 7124652
• 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): 01/17/2024

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: 04/13/2023
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2006
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown