MAUDE Adverse Event Report: ST PAUL PNEUPAC VR1; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	520A1299US
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator would not ventilate.No patient involvement or injury was reported.
Additional Manufacturer Narrative
A sample was received to perform an investigation.A visual inspection of the returned ventilator found the tamper seals intact.The device was received in with a cracked patient valve assembly, no other apparent physical damages.Functional testing of the device was performed by connecting to an o2 source and powered on to check various settings.The reported problem was duplicated.The continuous flow was discovered at the adult settings on maximum.The cause of the problem was due to a faulty rolling diaphragm.The problem was resolved by replacing the rolling diaphragm.A device history record (dhr) review was not performed because the results of the complaint investigation did not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

• Brand Name: PNEUPAC VR1
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14635672
• Report Number: 3012307300-2022-11201
• Device Sequence Number: 17617662
• Product Code: BTL
• UDI-Device Identifier: 10610586045721
• UDI-Public: 10610586045721
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051322
• 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
• Report Date (Section B): 06/08/2022

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
• Device Model Number: 520A1299US
• Device Catalogue Number: 520A1299US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2009
• 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