MAUDE Adverse Event Report: PNEUPAC; VENTILATOR

Model Number PARA PAC

Device Problem Circuit Failure (1089)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information received a smiths medical ventilators|pneupac ventilators parapac plus circuit outlet rotates and unit does not get higher pressures.No patient adverse events reported.

Manufacturer Narrative

Other text: one device was received for evaluation.Visual inspection of the device found to be in good physical condition.Device underwent functional testing, confirming the reported customer complaint.The patient outlet fitting noted to be loose.Problem source determined to be user interface.

• Brand Name: PNEUPAC
• Type of Device: VENTILATOR
• MDR Report Key: 10994882
• MDR Text Key: 221220389
• Report Number: 3012307300-2020-12295
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PARA PAC
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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