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U.S. Department of Health and Human Services

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

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AMBU A/S AMBU SPUR II MANUAL RESUSCITATOR Back to Search Results
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.
 
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Brand NameAMBU SPUR II
Type of DeviceMANUAL 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 Key8163246
MDR Text Key130308538
Report Number9610961-2018-00009
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152931
Number of Events Reported1
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
Date FDA Received12/13/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number520611001
Device Lot Number1000129914
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/19/2018
Event Location Hospital
Date Report to Manufacturer11/19/2018
Date Manufacturer Received11/19/2018
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 Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
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