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

Model Number 520611001

Device Problem Inflation Problem (1310)

Patient Problems Low Oxygen Saturation (2477); No Code Available (3191)

Event Date 02/05/2020

Event Type  malfunction  

Event Description

Patient was found unresponsive in room by bedside rn, oxygen saturation 14%.Crash cart brought into patient room and crisis rn instructed staff to pull ambu bag from crash cart.When ambu bag was placed on patient to begin bagging, the equipment was not properly inflating to be able to push air to the patient.

• 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: 10009410
• MDR Text Key: 189330547
• Report Number: 10009410
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 520611001
• Device Catalogue Number: 520611001
• Device Lot Number: 1000311255
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2020
• Event Location: Other
• Date Report to Manufacturer: 04/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1