MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS 300 VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	P300NJJP
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a sound of oxygen leaking from the air outlet when oxygen pressure was applied.The fault occurred while checking before in use with the patient.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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.
Additional Manufacturer Narrative
One device was received for investigation.The device was functionally tested, and the investigation could not reproduce the reported audible leakage.However, the investigation did identify a continuous flow issue.This issue was traced to the device o-ring and input manifold components, which were determined to be faulty.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.The device o-ring was replaced, and the device passed all testing.

• Brand Name: PNEUPAC PARAPAC PLUS 300 VENTILATOR
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21047956
• Report Number: 3012307300-2024-15659
• Device Sequence Number: 16996400
• Product Code: BTL
• UDI-Device Identifier: 35019315107270
• UDI-Public: (01)35019315107270(11)161027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: P300NJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/05/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2016
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown