MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CAP PNEUPAC VENTILATION; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	VR1AIRNJJP
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device had air leaking.There were no patient harm or adverse event reported as a result of the event.
Additional Manufacturer Narrative
Device evaluation: one device was received for device analysis.Functional testing and visual inspection performed.The customer reported complaint was confirmed in that a gas leak was identified during testing.The root cause was due to a tube inside the main unit coming off.The internal tube was reconnected to correct the issue.

• Brand Name: CAP PNEUPAC VENTILATION
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21734520
• Report Number: 3012307300-2025-03552
• Device Sequence Number: 14480354
• Product Code: BTL
• UDI-Device Identifier: 35019315074862
• UDI-Public: (01)35019315074862(11)190327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: VR1AIRNJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2019
• 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