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

Catalog Number	120002
Medical Device Problem Code	Tidal Volume Fluctuations (1634)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.Investigation 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.
Event or Problem Description
It was reported that the volumes high and rates low, especially at the 13000 over 8 and 1000 over 12 settings.Patient involvement unknown.
Event or Problem Description
Additional information received on 07-oct-2023 via email: event occurred during preventative maintenance.
Additional Manufacturer Narrative
Other: d4 udi: (b)(4).One device was received for investigation.The device was visually inspected and functionally tested.The reported problem was duplicated.The complaint is confirmed.The tidal volume is over spec and the frequency is under spec for air mix as well as nam.This was caused by the device being out of calibration.The frequency needle valve was readjusted.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.G2 email is: (b)(4).

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17721525
• Report Number: 3012307300-2023-08822
• Device Sequence Number: 15247972
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: 10610586045479
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/20/2024

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 Catalogue Number: 120002
• Was Device Available for Evaluation?: No
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 03/27/2024
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/31/2023; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2007
• 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