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

Model Number	150003
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 ventilator was not working and was not turning on.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Evaluation and health impact codes: updated device evaluation: one device was returned for investigation.Visual inspection noted the device was received in with normal wear and tear over time.Functional testing found the device's cycles and electronic system was functioning as intended.The complaint was not confirmed.The most probable root cause is intermittent failure due to the age of the device.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.Replaced interface board as preventative maintenance (pm).Installed mri battery, sintered filters, and o-rings for the pm.Adjusted oxygen concentration control to tolerance.Performed pm, cleaned unit and affixed new service label.Device passed all functional testing after the completed repairs.

• Brand Name: PNEUPAC BABYPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16542009
• Report Number: 3012307300-2023-02439
• Device Sequence Number: 6325629
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K970158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 150003
• Device Catalogue Number: 150003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2008
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown