MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATORS PARAPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	120002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was not working correctly.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation 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: b5: describe event or problem: updated with additional information received.H3: device evaluated by manufacturer: updated.H6: event problem and evaluation codes: updated.H10: device evaluation: one ventilator device was returned to manufacturing for investigation.Visual inspection and functional testing were performed.Visual inspection of the returned device confirmed that the tamper seal was intact upon receipt, the device was received in with no apparent physical damage.Error codes or event history log (ehl) are not available for this device.After functional tests were performed, the customer reported issue was confirmed as the device failed the air entrainment nrv on airmix.The root cause is unknown, but a faulty alarm reed was detected.The alarm reed was replaced to correct the issue.The previous service history has been reviewed and deemed unrelated to the current customer reported reason.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.
Event or Problem Description
Additional information was received via email which confirmed that they noticed the issue while they were prepping and testing the vent.There was no patient involved.

• Brand Name: PNEUPAC VENTILATORS PARAPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; co queen of the valley hospit; minneapolis, MN 55442
• MDR Report Key: 16000308
• Report Number: 3012307300-2022-27919
• Device Sequence Number: 20517764
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: 10610586045479
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• 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): 06/20/2023

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: 120002
• Device Catalogue Number: 120002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2015
• 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