MAUDE Adverse Event Report: ST PAUL PARA PAC PLUS; VENTILATOR

Catalog Number PPT-BED-SETJP

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Event Description

Information received a smiths medical ppt-bed-setjp malfunctioned.During the pre-use check, the found difficulty in putting a p310 (a parapac plus) in the basket (a pppt-bed-set) and taking the p300 out of it.No patient injury.

• Brand Name: PARA PAC PLUS
• Type of Device: VENTILATOR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11879275
• MDR Text Key: 252706634
• Report Number: 3012307300-2021-05021
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PPT-BED-SETJP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2021
• 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