MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PEDIATRIC 1ST RESPONSE MANUAL RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 8520BMP

Device Problem Gas/Air Leak (2946)

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

Event Date 04/16/2021

Event Type  malfunction  

Event Description

It was reported the device was found to leak and would not hold pressure.No adverse effects reported.

• Brand Name: PEDIATRIC 1ST RESPONSE MANUAL RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11820120
• MDR Text Key: 250465307
• Report Number: 3012307300-2021-04297
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 15019517101119
• UDI-Public: 15019517101119
• Combination Product (y/n): N
• PMA/PMN Number: K014115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8520BMP
• Device Catalogue Number: 8520BMP
• Device Lot Number: 181114
• 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: N
• Patient Sequence Number: 1