MAUDE Adverse Event Report: ST PAUL VENTILATORS PNEUPAC ACCESSORIES; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE

Model Number	120002
Medical Device Problem Code	Output above Specifications (1432)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the relief pressure valve at 40 and 60 settings is relieving too high.No patient injury reported.
Additional Manufacturer Narrative
The device was returned undamaged for evaluation.Failed relief pressure check for the 60 threshold setting was performed.Pressure relieved at 75, which is above the 48-66 spec.The alarm reed was replaced and now the pressure relieves at 55, which is within specification.The reported issue of relief pressure setting is relieving too high is confirmed.The root cause was determined as a faulty alarm reed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture, this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: VENTILATORS PNEUPAC ACCESSORIES
• Common Device Name: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 1235 e cherokee st; minneapolis, MN 55442
• MDR Report Key: 15396728
• Report Number: 3012307300-2022-18395
• Device Sequence Number: 12013561
• Product Code: BYE
• UDI-Device Identifier: 10610586045479
• UDI-Public: 10610586045479
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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: 120002V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown