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

Model Number P310NUS

Device Problem Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the device screw was stuck.This occurred while twisting the thread/stripping.In addition, when the operator tried to get the screw out as part of the preventative maintenance, they noticed that there was an issue with the screw, or pole back.No patient injury or complications were reported in relation to this event.

Event Description

Investigation completed on a smiths medical ventilator|pneupac ventilator parapac plus.

Manufacturer Narrative

Investigation completed on a smiths medical ventilators|pneupac ventilators parapac plus .The complaint was verified as tried to screw that holds the pole mount back of the case was unable to because fitting was stripped.The cause was isolated to mounting insert on the chassis bracket has been damaged and is spinning loosely and the user interface was the cause of this issue.Action was taken to replace the damaged chassis bracket.The physical conditions of the device revealed a stripped case fitting and mounting insert.Mamometer is out of specification, front panel is bent above the frequency knob.The device was updated with a new service kit which included: calibrated cpap ctrl needle, performed pm, tested unit, replaced damaged chassis bracket, replaced out of specification manometer, replaced damaged oxygen indicator, fixed bent front panel assembly.Device then passed all functional and delivery testing.

Event Description

Additional information received stating the device did not produce an alarm, no patient injury resulted, and no medical intervention was required.

Manufacturer Narrative

Additional information: b5, h6.

• Brand Name: PNEUPAC VENTILATORS PARAPAC PLUS
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 9728784
• MDR Text Key: 180114677
• Report Number: 3012307300-2020-01425
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P310NUS
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• 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