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

Catalog Number 520611001

Device Problem Disconnection (1171)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Additional information received by medwatch report nov 19, 2018; according to medwatch report customer is questioning if "the bag popping of and not holding peep have contributed to patient outcome".Causal relationship has not been established: there is not enough data provided by the hospital to establish whether or not the device contributed to a death (why did patient need resuscitation, was patient outcome related to patient's underlying conditions, why did therapist not change to other means of ventilation).Device was not returned for investigation.Investigation of similar devices identified the outlet connector not being in compliance with iso 5356-1 which could contribute to the peep valve detaching from the connector.However, the resuscitator can still perform its intended use "pulmonary resuscitation" without the peep valve being attached.Patient connector was found to be in compliance with iso 5356-1.Since the resqpod was not returned for investigation it can not be concluded if the resqpod malfunctions or if is not in compliance with iso 5356-1.

Event Description

Patient coding.Ambu spru ii removed from packaging and placed into use.Peep valve disconnected from outlet connector during use and resqpod (not an ambu device) placed between et tube and resuscitator dis-connector from patient connector on every breath causing the therapists to hold the resqpod onto the resuscitator.Therapist should hold the tube with spare hand but was required to keep the resuscitator, peep valve and resqpod in place.Patient expired.

• 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): AMBU 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: 8163246
• MDR Text Key: 130308538
• Report Number: 9610961-2018-00009
• 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: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2018,12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520611001
• Device Lot Number: 1000129914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death