MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PNEUPAC PARAPAC PLUS, JAPANESE PANEL; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	P300NJ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patent use the device had an oxygen leak.Adverse patient effects are unknown.
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.One device was received.No physical damage was found on the device.Per functional testing, oxygen gas was leaking from the supply gas pressure indicator inside the main unit.The complaint was confirmed.The root cause was the supply gas pressure indicator assembly.It was unknown what caused the condition.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 supply gas pressure indicator was replaced.The device passed all functional and delivery tests.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: PNEUPAC PARAPAC PLUS, JAPANESE PANEL
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; enterprise way; luton LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18402448
• Report Number: 9611178-2023-00012
• Device Sequence Number: 14121941
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)170213
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2024

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 Model Number: P300NJ
• Device Catalogue Number: P300NJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 07/30/2024; 07/30/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 08/07/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2017
• 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