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

Catalog Number	150003
Medical Device Problem Codes	Fracture (1260); Defective Component (2292); Component Missing (2306); Battery Problem (2885); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); 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: unknown.No information has been provided to date.E3.Initial reporter occupation: operations support specialist.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 there was physical damage to the battery well and two missing knobs.There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: customer reported that the device had physical damage to the battery well and was missing two knobs was verified during visual inspection.The cause was due to mishandling of the device.The battery compartment and knobs were replaced to correct the problem.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 VENTILATOR W/ 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18935757
• Report Number: 3012307300-2024-01481
• Device Sequence Number: 20593754
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: (01)10610586045578(11)051024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2005
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LN 150003 SN (B)(6)
• Patient Sex: Unknown