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

Model Number	120002
Medical Device Problem Codes	Defective Component (2292); Pressure Problem (3012)
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's knobs were broken and the device was not reaching pressure.No patient injury, adverse affects, or patient involvement were reported.
Additional Manufacturer Narrative
Other, other text: the device was returned for evaluation.The knobs were not broken but loose on the spindle.All pressure measurements were within specification, but the manometer was not stable due to the lack of maintenance by the user.During functional checks, additional issues were found; the demand valve was faulty, and the oxygen concentration was measuring too high.However, the primary problem was the demand body assembly, and replacement was made.Additional repairs were performed.Preventive maintenance was completed.No previous service history was found.The manufacturing device history record review is not relevant to the investigation due to the age of the device and the problem source being user interface.

• Brand Name: PNEUPAC PARAPAC MEDIC MODEL
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• 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; minneapolis, MN 55442
• MDR Report Key: 14986979
• Report Number: 3012307300-2022-13261
• Device Sequence Number: 19266821
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: 10610586045479
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• 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): 11/14/2022

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
• Device Model Number: 120002
• Device Catalogue Number: 120002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 07/20/2022; 11/08/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/19/2022; 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/1980
• 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