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

Model Number	130003
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was received for evaluation, in good condition.Functional testing was performed: power on sequence was normal.It was noted however, that both the low pressure and high pressure alarms did not activate both visually and audibly when checked after about 2 hours into test run.Cycle led also did not function when back pressure of 15 cm h2o was applied.This confirmed the reported issue.The cause of the issued was determined to be a faulty alarm board.Action(s) taken to mitigate the reported issue(s): replaced main alarm board part, performed a second test run over a 4 hour period, tested low and high pressure alarm functions at various times during test run; alarms activated as expected, device passed all functional tests.
Event or Problem Description
It was reported that the device turns off while in use.No patient injury was reported.

• Brand Name: PNEUPAC
• 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: 15605938
• Report Number: 3012307300-2022-24038
• Device Sequence Number: 16713891
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 130003
• Device Catalogue Number: 130003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2012
• 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