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

Model Number 520211010

Patient Problems Failure of Implant (1924); Low Oxygen Saturation (2477); Diminished Pulse Pressure (2606)

Event Date 07/13/2023

Event Type  malfunction  

Event Description

Patient was intubated.End-tidal carbon dioxide (etco2) cap was placed and activated via an ambu a/s spur ii adult resuscitator bag to confirm proper placement of endotracheal tube (eet).Etco2 did not show color change.Ett was immediately removed and replaced.After the 3rd attempt of failed etco2 color change, via ambu bag, ambu bag was replaced.Positive color change was achieved and patients sats began to rise.Pulse was lost and compressions where initiated.Upon return of spontaneous circulation (rosc), patient was placed on ventilator.After inspection of the ambu bag, it was noticed that there was a sizable tear on the inflation bag at one of the seams.

• Brand Name: SPUR® II ADULT RESUSCITATOR SINGLE PATIENT USE RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU A/S; 6721 columbia gateway drive; suite 200; columbia MD 21046
• MDR Report Key: 17479300
• MDR Text Key: 320586835
• Report Number: 17479300
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2023,07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 520211010
• Device Catalogue Number: 520211010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male
• Patient Weight: 68 KG