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

Model Number	150003
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was not giving correct o2.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation 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.
Additional Manufacturer Narrative
Other, other text: b5: additional information.H6: event problem and evaluation codes: updates not required.H10: device evaluation 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.
Additional Manufacturer Narrative
One device was received for evaluation without a valve diaphragm.No other unacceptable physical damages were found.A oxygen concentration control calibration check was performed after installing the valve diaphragm.The reported problem was duplicated.The o2 concentration was out of spec.Once the oxygen concentration control was adjusted the reported issue was resolved.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; bio-one, inc.; minneapolis, MN 55442
• MDR Report Key: 16070262
• Report Number: 3012307300-2022-28283
• Device Sequence Number: 6334185
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 06/05/2023

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: 12/13/2022
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/04/2023; 05/24/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/09/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2013
• 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