MAUDE Adverse Event Report: ST PAUL PNEUPAC; VENTILATOR

Model Number BABY PAC

Device Problem Defective Alarm (1014)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information received a smiths medical ventilators|pneupac ventilators babypac revealed out of box failure: unit is not showing alarms, lights in cpap plus imv modes , does not maintain peep in cmv and peep.No patient adverse events reported.

Manufacturer Narrative

Other, other text: one device was received for evaluation.Visual inspection of the device was found to be in fair condition.Device underwent functional testing, confirming the reported customer complaint.Internal inspection found loose screws on the variable relief valve assembly; problem source determined to be user interface.

• Brand Name: PNEUPAC
• Type of Device: VENTILATOR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10983981
• MDR Text Key: 220682873
• Report Number: 3012307300-2020-12266
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (y/n): N
• PMA/PMN Number: K970158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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: BABY PAC
• Device Catalogue Number: 150003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1