MAUDE Adverse Event Report: RESMED LTD STELLAR 150 GERMANY (GMBH)

Model Number 24141

Device Problems Device Alarm System (1012); Failure to Charge (1085); Protective Measures Problem (3015); Unexpected Shutdown (4019)

Patient Problem Respiratory Distress (2045)

Event Type  malfunction  

Manufacturer Narrative

The stellar device was returned to resmed for an investigation.The investigation methods, results and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Per the stellar user guide, (contraindication): the stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation.The stellar is not a life support ventilator.(b)(4).

Event Description

It was reported to resmed that a stellar device powered off without alarming during a visit with the doctor.It was reported that the patient's state of health deteriorated and the doctor called an ambulance to take the patient to the hospital.No further impairment of health was reported.

Event Description

It was reported to resmed that a stellar device powered off without alarming during a visit with the doctor.It was reported that the patient's state of health deteriorated and the doctor called an ambulance to take the patient to the hospital.No further impairment of health was reported.

Manufacturer Narrative

The stellar device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint and revealed an error message (sf25) related to the internal battery.Performance testing confirmed the battery does not charge.The internal battery was replaced to address the reported complaint.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported event was due to a faulty internal battery.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Per the stellar user guide, (contraindication): the stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation.The stellar is not a life support ventilator.Resmed reference #: (b)(4).

• Brand Name: STELLAR 150 GERMANY (GMBH)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8238176
• MDR Text Key: 132915125
• Report Number: 3004604967-2019-00041
• 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
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 24141
• Device Catalogue Number: 24141
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/27/2019
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1