MAUDE Adverse Event Report: AMBU A/S SPUR® II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 520211010

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

While preparing to intubate a patient, o2 saturations were noted to be decreasing.Assessment by bedside personnel (nursing, respiratory, and doctor) found ambu (spur® ii adult resuscitator) bag was found to be leaking.Device switched out with rapid improvement in oxygen saturation.

• Brand Name: SPUR® II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU A/S; 6230 old dobbin lane, suite 250; columbia MD 21045
• MDR Report Key: 12727447
• MDR Text Key: 279333286
• Report Number: 12727447
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 520211010
• Device Catalogue Number: 520211010
• Device Lot Number: 1000502949
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 117