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

Model Number	120002
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was not alarming.No patient involvement was reported.
Additional Manufacturer Narrative
New information submitted by the customer, update of the serial number of the device: item number 120002 with serial number (b)(6).The information was updated in the complaint.H10: device evaluation: device was returned for device evaluation which is anticipated but not yet begun.
Additional Manufacturer Narrative
Other, other text: manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.The device was received missing the on/off control knob and relief pressure knob.The reported issue was duplicated; the pneumatic alarm was not heard.The root cause was found to be normal wear and tear of components: (nrv) non return valve assembly, alarm reed, and airmix switch.Upgrades were performed for the nrv assembly and alarm reed.Cleaning was done for the airmix switch.The device passed functional tests after repairs and calibration.D5 and e4 are unknown, corrected data: the manufacture date was not updated when the serial number changed on the previous supplemental report.

• Brand Name: PNEUPAC PARAPAC
• 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: 14166304
• Report Number: 3012307300-2022-06772
• Device Sequence Number: 5933594
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: 10610586045479
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/13/2022

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
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 05/02/2022; 08/17/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/24/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2018
• 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