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

Catalog Number 520611001

Device Problems Detachment of Device or Device Component (2907); Pressure Problem (3012)

Patient Problem Death (1802)

Event Date 01/04/2019

Event Type  Death  

Manufacturer Narrative

Two spur ii resuscitator were returned from customer.Connector test was performed and showed that the patient connector of spur ii is in compliance with iso 5356-1 anaesthetic and respiratory equipment - conical connectors - part 1: cones and sockets.The resqpod used in combination with spur ii is a non ambu device.Please note that no causal relationship has been established between resqpod detaching and patient outcome.According to customer "it is difficult to know if the patient was affected as he did not survive the code".

Event Description

Patient was coding.Resqpod (non ambu device which is an impedance threshold device delivering intrathoracic pressure regulation therapy) would not stay attached to ambu spur ii resuscitator during use.

• Brand Name: AMBU SPUR II
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• Manufacturer (Section G): AMNBU INC; 6230 old dobbin lane; suite 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; 6230 old dobbin lane; suite 250; columbia, MD 21045 ; 4107686464
• MDR Report Key: 8292995
• MDR Text Key: 134627340
• Report Number: 9610961-2019-00002
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 05707480032938
• UDI-Public: 05707480032938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520611001
• Device Lot Number: 1000089778
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2019
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death