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

Model Number	510A1960NONEU
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the air indicator was faulty.The event occurred, during testing.There was no patient involvement.
Additional Manufacturer Narrative
B3:.Date of event: unknown.No information has been provided to date.Investigation summary: one device was received in good condition, except for the air indicator not working.The device passed all functional testing.The complaint was confirmed, through visual inspection.The air indicator will be replaced and functional testing performed after repairs.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.

• Brand Name: PNEUPAC VENTILATORS BABYPAC
• 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: 19806054
• Report Number: 3012307300-2024-06470
• Device Sequence Number: 8302766
• Product Code: BTL
• UDI-Device Identifier: 15019517181173
• UDI-Public: (01)15019517181173(11)151221
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043495
• 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
• Report Date (Section B): 07/23/2024

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: 510A1960NONEU
• Device Catalogue Number: 510A1960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2015
• 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