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

Catalog Number	520611001
Health Effect - Clinical Code	Death (1802)
Date of Event	01/04/2019
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• MDR Report Key: 8292995
• Report Number: 9610961-2019-00002
• Device Sequence Number: 11343326
• Product Code: BTM
• UDI-Device Identifier: 05707480032938
• UDI-Public: 05707480032938
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K152931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2019
• Report Date (Section F): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 520611001
• Device Lot Number: 1000089778
• Was Device Available for Evaluation?: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death