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

Model Number	150003
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.Tamper seal was intact.Battery holder was found corroded.Device will not power on.On closer inspection, the battery holder appeared to be very corroded.The root cause of the reported issue was not able to be determined.Actions were taken to mitigate the reported issue: replace damaged battery holder.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.
Event or Problem Description
It was reported that the battery door holder was found damaged during setup check.The unit release pressure is also releasing slow.No patient involvement.

• Brand Name: PNEUPAC VENTILATORS BABYPAC
• 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: 16600323
• Report Number: 3012307300-2023-02958
• Device Sequence Number: 6165245
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2015
• 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