MAUDE Adverse Event Report: PNEUPAC PARAPAC PLUS VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 310

Device Problems No Flow (2991); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information was received indicating that a valve to a smiths medical pneupac parapac plus ventilator would not deliver breath.It was reported that the unit was connected to test lung and set to ventilate, as it provides set pressure, but won't release.There were no reported adverse effects.

Manufacturer Narrative

One pneupac ventilator was returned for analysis because the valve was stuck.The technician performed the peep control test.The peep test was at high value during the max peep settings.The peep control needle valve was found needing adjustments.The solution was to reset the peep control needle valve.

• Brand Name: PNEUPAC PARAPAC PLUS VENTILATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 10437419
• MDR Text Key: 203860921
• Report Number: 3012307300-2020-08389
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 35019315107263
• UDI-Public: 35019315107263
• Combination Product (y/n): N
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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: 310
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1