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

Catalog Number	150003
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was recorded that pm and alarm will not sound even with new battery.Patient involvement is unknown.
Additional Manufacturer Narrative
Other text: 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
Additional information was received.Event date provided.Event occured in a hospital.
Additional Manufacturer Narrative
Other text: d4: udi updated - (b)(6).H6: evaluation codes updated.Device evaluation: one device was received.A visual inspection found that the exhalation diaphragm is missing.During the functional testing, it was found that the recommended service was due, but the alarm power issue could not be duplicated.The cause of the issue was found to be that routine maintenance was needed.An mri compatible battery, sintered filters, washers, o rings and the missing exhalation diaphragm were replaced.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.Service history review identified this device has not been in for service previously.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).

• 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: 17847789
• Report Number: 3012307300-2023-09449
• Device Sequence Number: 11840461
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 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 Catalogue Number: 150003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/20/2023
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 04/10/2024
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/16/2023; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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