MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATORS VENTIPAC; BREATHING CIRCUIT CIRCULATOR

Catalog Number 510A2357

Device Problem Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the demand valve not functioning.No additional information known.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms#(b)(4).The device was received for evaluation.Visual inspection showed labels were intact.Device was received in with damaged battery compartment.All blocks were found loose within the device.During functional check, the reported complaint was duplicated.The device was connected to an oxygen source and demand function testing was performed.Root cause was a faulty demand valve; valve was replaced.

• Brand Name: PNEUPAC VENTILATORS VENTIPAC
• Type of Device: BREATHING CIRCUIT CIRCULATOR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 13193443
• MDR Text Key: 283479143
• Report Number: 3012307300-2022-00297
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 510A2357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1