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

Model Number	150003
Medical Device Problem Codes	Defective Device (2588); Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
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 required.
Event or Problem Description
It was reported, that the inspiratory time and expiratory time was off.There has been no report of patient involvement, or no observable clinical symptoms, or a change in symptoms identified in the patient.
Event or Problem Description
Additional information received: the event happened during testing on (b)(6)2023.No patient harm/injury.
Additional Manufacturer Narrative
B3, b5, and h6 hecs codes: updated.
Additional Manufacturer Narrative
D3, g1,2 email is: d3, g1, 2 email is: regulatory.Responses@icumed.Com.One device was received in with no physical damage.Cmv+peep and imv+cpap selection from the front panel have been whited out.Per functional testing, the expiratory time was low on nam at.07 on minimum settings.The complaint was confirmed.The root cause was a dirty valve diaphragm.It was unknown what caused the condition.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 valve diaphragm.Replaced faulty variable relief valve.Replaced damaged exhalation valve element.Installed mri battery, sintered filters, and o-rings for preventative maintenance (pm).Adjusted "texp" and "tins" control, peep/cpap control, peak inspiratory control and o2 concentration control to tolerance.Performed pm, recalibrated unit, cleaned, and affixed new service label.The device passed all functional and delivery tests.

• Brand Name: PNEUPAC BABYPAC TRANSPORT 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16737284
• Report Number: 3012307300-2023-04096
• Device Sequence Number: 6663346
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 01/15/2024

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: 03/30/2023
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 12/18/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/29/2023; 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2018
• 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