MAUDE Adverse Event Report: ST PAUL PNEUPAC PARAPAC MEDIC VENTILATOR

Model Number 120003

Device Problem Gas Output Problem (1266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: device evaluation- the device was returned for evaluation.The device was given functional testing: this showed the device leaked oxygen from the demand detector assembly.The cause of the issue was not confirmed.

Event Description

It was reported the device o2 supply cut off while connected to patient.Reporter stated the user was alerted to the issue because patient's o2 saturation had decreased.No adverse effects reported.

• Brand Name: PNEUPAC PARAPAC MEDIC VENTILATOR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10953539
• MDR Text Key: 219881117
• Report Number: 3012307300-2020-12161
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: 10610586045486
• Combination Product (y/n): N
• PMA/PMN Number: K020899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• 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: No Information
• Device Model Number: 120003
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/05/2020
• 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