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

Model Number 522611000

Device Problems Component Missing (2306); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 01/25/2021

Event Type  Death  

Event Description

Patient was not receiving adequate ventilation during code blue resuscitation event.It was identified that the ambu bag was missing the white screw in pressure limiting cap.Manufacturer indicated cap is designed to be removable to allow user to clear the valve chamber.The pressure limiting cap should never be removed during operation.Our organization identified ambu packaging can be opened and product manipulated through the package handle.Packaging can be opened/closed and appear unopen.Covid air-borne precaution filters have changed resuscitator product handling for hospitals globally.Filter connections can be confusing (many different products).Opportunity for manufacturer to create an ambu bag that does not have removable piece that makes product inoperable.Other option is to visually indicate piece should not be removed.

• 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 ln ste 250; columbia MD 21045
• MDR Report Key: 11473120
• MDR Text Key: 239444932
• Report Number: 11473120
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 522611000
• Device Catalogue Number: 522611000
• Device Lot Number: 1000422792
• 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: 02/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death