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

Model Number	150003
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device failed the preventive maintenance.Release valve pressure alarm calibration.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.
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.
Additional Manufacturer Narrative
Other, other text: d4 udi (b)(4).Device evaluation: we received a device for investigation.Visual inspection performed showed device had no apparent physical damages.Functional test performed, relief valve checks.Reported complaint duplicated measurements are off and reading low.Relief valve is out of spec and unable to adjust.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: PNEUPAC BABYPAC VENTILATOR
• 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: 16435983
• Report Number: 3012307300-2023-01618
• Device Sequence Number: 3126464
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/20/2024

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: 150003
• Device Catalogue Number: 150003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/08/2023
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 12/09/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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