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

Model Number	130003
Medical Device Problem Code	Gas/Air Leak (2946)
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 and d4: udi section are 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 required.
Event or Problem Description
It was reported that the device had an internal leak.Patient involvement is unknown.
Additional Manufacturer Narrative
Device evaluation: one device was received for investigation.Visual inspection showed the device was received in with a cracked gas supply indicator cover.Functional testing confirmed the complaint when the device leaked.Root cause was attributed to the worn tubing on the gas supply indicator.A device history report (dhr) review was not completed as the issue was service related.Replaced tubing, gas supply indicator, worn tall pillar due to removal.Performed preventative maintenance (pm), functional tests, cleaned and affixed new service label.Device passed all functional tests.
Event or Problem Description
Additional information received via email.No adverse patient effects were reported by the customer.

• Brand Name: PNEUPAC VENTILATORS VENTIPAC
• 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: 16837269
• Report Number: 3012307300-2023-04757
• Device Sequence Number: 12646542
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2023

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?: No
• Date Returned to Manufacturer: 04/25/2023
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 08/23/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/07/2023; 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2005
• 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