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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product has a gas leak and spo2 doesn't increase even it is connected.There was no patient involvement, and no patient harmed reported.
Additional Manufacturer Narrative
B3: date of event is unknown.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.No abnormality related to the reported event was confirmed on the product's appearance during the visual inspection.There was no abnormalities found in the product's operation during functional testing.The cause is unknown as the event did not recur.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• 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: 20032979
• Report Number: 3012307300-2024-07949
• Device Sequence Number: 15080042
• Product Code: BTL
• UDI-Device Identifier: 35019315074862
• UDI-Public: (01)35019315074862(11)180315
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: VR1AIRNJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/01/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2018
• 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