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

Catalog Number	150003
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
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 device was not holding peep in cmv plus peep.Issue was found during testing.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluation: customer reported issue that the ventilator was not holding positive end-expiratory pressure (peep) in continuous mandatory ventilation (cmv).The fault was verified while testing the peep/continuous positive airway pressure (cpap) control.The cause was a missing valve diaphragm within the patient valve assembly.Replaced patient valve assembly to correct the problem, and the device passed all functional tests after the 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 BABYPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• 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: 18908769
• Report Number: 3012307300-2024-01377
• Device Sequence Number: 6188951
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: (01)10610586045578(11)131010(21)1307153
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• 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: 02/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2013
• 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