MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; MANUAL RESUSCITATION 1RST RESPONSE PEDIATRIC

Catalog Number 8520BMP

Device Problem Gas/Air Leak (2946)

Patient Problem Endocarditis (1834)

Event Date 04/16/2021

Event Type  malfunction  

Event Description

Information received a smiths medical breathing|portex manual resuscitation 1st response pediatric resuscitators plv opens, when closing the plv is making loud noises and leaking pressure, doesn't seem to be sealing.No patient adverse events reported.

• Brand Name: PORTEX
• Type of Device: MANUAL RESUSCITATION 1RST RESPONSE PEDIATRIC
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11829421
• MDR Text Key: 250797973
• Report Number: 3012307300-2021-04385
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8520BMP
• Device Lot Number: 181203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1