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

Catalog Number	520611001
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• MDR Report Key: 8163246
• Report Number: 9610961-2018-00009
• Device Sequence Number: 16634529
• 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,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2018
• Report Date (Section F): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

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