MAUDE Adverse Event Report: AMBU A/S SPUR II RESUSCITATOR; MANUAL RESUSCITATOR

Catalog Number 325002002

Device Problem Material Deformation (2976)

Patient Problems Cardiac Arrest (1762); Death (1802); Respiratory Distress (2045)

Event Type  Death  

Manufacturer Narrative

Device was not returned for investigation.Lot no.Was not provided.Since device was not returned and information was limited, the root cause of the fault could not be established.

Event Description

Responder called to an unconscious/noisy breathing adult patient, on arrival patient was in full cardiac arrest.Responder opened a sealed resuscitator (spur ii) as per load list.Responder was unable to confirm a seal to ventilate the patient.On examination of the device it was found that the face mask was deformed.

• Brand Name: SPUR II RESUSCITATOR
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• Manufacturer (Section G): AMBU INC; 6230 old dobbin lane; suite 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• MDR Report Key: 8425361
• MDR Text Key: 138952338
• Report Number: 9610691-2019-00004
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 325002002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death