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

Model Number 120003

Device Problems Tidal Volume Fluctuations (1634); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received that a smiths medical pneupac parapac ventilator would not provide any volume when on patient.No adverse patient effects were reported.

Manufacturer Narrative

Additional information has been received from the customer confirming that the unit would not provide volume when placed on the patient but worked when off the patient.

Manufacturer Narrative

Evaluation results: one pneupac ventilators ventipac was returned for investigation in an undamaged condition.The tamper seal was intact.The investigator was unable to replicate the customer reported product problem (failure to provide volume).The investigator found that the device was able to deliver to the test lung on 100 % oxygen and air mix within specifications.However, the investigator noticed on air mix that the gas supply indicator fluctuated during ventilation.This did not happen on the 100 % oxygen setting.It stayed constant.The investigator was unable to replicate the problem.No fault was found with the device.

• Brand Name: PNEUPAC PARAPAC VENTILATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 9655272
• MDR Text Key: 177386565
• Report Number: 3012307300-2020-00651
• 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,Followup,Followup
• Report Date: 07/11/2020

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: 01/07/2020
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 02/04/2020; 06/12/2020
• Supplement Dates FDA Received: 03/03/2020; 07/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1