MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC BABYPAC WITH ALARMS; VENTILATOR, CONTINUOUS, FACILITY USE

Catalog Number	150003
Medical Device Problem Codes	Gas Output Problem (1266); Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.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 unit was not getting correct output.The issue was found during use but they took it off and did not use it on the patient.No additional details available at this time.
Additional Manufacturer Narrative
H3: one device was returned for analysis in used condition.Visual inspection showed the device was in used condition.Service history identified the complaint was not related to a previous service of the device within the review period.Functional testing was performed and the customer reported issue was confirmed.The cause was identified to be a calibration issue.The tinsp.& texp.Were calibrated to resolve this issue.

• Brand Name: PNEUPAC BABYPAC WITH ALARMS
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19071078
• Report Number: 3012307300-2024-02292
• Device Sequence Number: 11926893
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: (01)10610586045578(11)060419
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K970158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: Other
• Device Catalogue Number: 150003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2006
• 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