MAUDE Adverse Event Report: RESMED GERMANY INC. VELIA, FUKUDA - JAPAN

Model Number 24158

Device Problem Device Alarm System (1012)

Patient Problem Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not yet been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Note: per the stellar 100 user guide, (contraindication), the stellar is contraindicated in patients who are unable to endure more than a brief interruption in ventilation, the stellar is not a life support ventilator.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a stellar device's disconnection alarm failed to trigger when a hospital patient's mask fell off.Per the reporter, the patient was without ventilation for about 2.5 hours.The delay in ventilation response caused the patient to suffer an acute heart failure.The patient was stabilized.

Manufacturer Narrative

The stellar device was not returned to resmed for an extensive engineering investigation.Review of the device data logs confirmed that no circuit disconnect alarm was triggered in the device during patient use.The investigation determined that the reported circuit disconnected alarm failure was due to a software issue.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Note: per the stellar 100 user guide, (contraindication), the stellar is contraindicated in patients who are unable to endure more than a brief interruption in ventilation, the stellar is not a life support ventilator.(b)(4).

Event Description

It was reported to resmed that a stellar device's disconnection alarm failed to trigger when a hospital patient's mask fell off.Per the reporter, the patient was without ventilation for about 2.5 hours.The delay in ventilation response caused the patient to suffer an acute heart failure.The patient was stabilized.

• Brand Name: VELIA, FUKUDA - JAPAN
• Manufacturer (Section D): RESMED GERMANY INC.; fraunhoferstr. 16; martinsried 82152
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 6054911
• MDR Text Key: 58310065
• Report Number: 3004604967-2016-01152
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K122715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24158
• Device Catalogue Number: 24158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/06/2017
• Device Age: 3 MO
• Date Manufacturer Received: 09/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1