MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTIPAC VENTILATOR; POWERED EMERGENCY VENTILATOR

Model Number 130003

Device Problem Gas Output Problem (1266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.The device was found to have a leaking demand valve, faulty main alarm pcb board, damaged bezel, damaged battery holder and damaged relief valve.In order to get device to function as per specifications, all components listed required replacement.

Event Description

It was reported the device's inspiratory flow fluctuated.No adverse effects reported.

• Brand Name: PNEUPAC VENTIPAC VENTILATOR
• Type of Device: POWERED EMERGENCY VENTILATOR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10950148
• MDR Text Key: 219879906
• Report Number: 3012307300-2020-12126
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (y/n): N
• PMA/PMN Number: K030803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/04/2020

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 Model Number: 130003
• Device Catalogue Number: 130003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1