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

Model Number 120003

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

One pneupac parapac ventilator was returned for analysis.The housing was observed to be bent, the front panel was bent, there was a crack in the bezel, the manometer was out of specification, and the silence button does not engage upon visual inspection.Oxygen was then connected to the supply and unit was powered on; unit cycled for 30 minutes.The unit was inspected internally revealing a loose dump valve.Based on the evidence, the root cause is unknown as the complaint was not confirmed.

Event Description

Information was received indicating that a smiths medical pneupac parapac ventilator was reported to be working intermittently by giving a breath, but upon breathing the patient's chest would not rise.There were no reported adverse patient effects.

• Brand Name: PNEUPAC PARAPAC VENTILATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10378526
• MDR Text Key: 202013606
• Report Number: 3012307300-2020-07925
• 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: 08/07/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 120003
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1