MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATORS BABY PAC; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	150003
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
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 ventilator connector where the circuit attaches was bent.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
No product was returned.The investigation was unable to determine the most probable cause as the device was not returned for evaluation.If the product is returned this complaint will be reopened for further investigation.Service history review identified the complaint was not related to a previous 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.D.4 full udi number: (b)(4).

• Brand Name: PNEUPAC VENTILATORS BABY PAC
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16745444
• Report Number: 3012307300-2023-04160
• Device Sequence Number: 12905648
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/12/2024

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
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2007
• 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