MAUDE Adverse Event Report: RESPIRONICS, INC REMSTAR AUTO, BLUETOOTH; VENTILATOR,NON-CONTINUOUS RESPIRATOR

Model Number 561CABT

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problems Bruise/Contusion (1754); Fall (1848); Anxiety (2328); Injury (2348)

Event Date 10/18/2015

Event Type  Injury  

Event Description

A patient alleges that when he woke up in the morning, his continuous positive airway pressure (cpap) device had turned off during the night.He experienced anxiety upon waking, stumbled out of bed, and bruised his nose from running into a wall and falling.On (b)(6) 2015, the manufacturer received new information that the patient had an ultrasound within a few days of the reported event, and now alleges he sustained an abdominal tear from the fall.To date, there is no report of medical intervention.Although the cpap device was not in use during the fall, the manufacturer is reporting this incident due to the report of the alleged serious injury.At this moment, the manufacturer does not have sufficient information to be able to confirm if the device performance caused or contributed to the alleged patient harm.The manufacturer has requested the return of the devices for evaluation.To date, no product has been returned.A follow up report will be filed upon completion of the manufacturer's investigation.

Manufacturer Narrative

The manufacturer received the cpap device, heated humidifier, sd card, power supply and ac power cord for investigation.Using the received sd card a data download was performed.The download indicates the cpap acquired data on (b)(6) 2015.A review of the data showed the cpap had no logged error codes that would have indicated an unintentional interruption of therapy.The data also showed nine sessions were logged with all sessions having started and stopped with a manual button press, and not due to the device turning off by itself.As received, the cpap did not power up due to a failure of the pca.The manufacturer is not able to determine when the failure occurred, however, it was after the last manual button press which ended the ninth therapy session.During the evaluation of the device at the manufacturer's product investigation laboratory, the device failed to power on.The failure of the device to power on is consistent with a failure of a component in the therapy pca.Based on the data pulled downloaded from device, this failure is not related to the customer complaint.The data shows that the device operated as designed during the therapy sessions for the dates when the device was in use by the patient.Patient labeling warns the user that if they detect any unexplained changes in the performance of the unit, if the unit is dropped or mishandled, if liquid or water is spilled into the enclosure or if the enclosure is broken, to stop using the device, unplug it and seek assistance from respironics or an authorized service center.The intended use of this device is only for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 66 pounds.The short-term loss of therapy for this patient class does not pose a significant health or safety risk.The manufacturer is unable to determine the root cause of the alleged event.Based on the information available the manufacturer concludes no further action is necessary.

• Brand Name: REMSTAR AUTO, BLUETOOTH
• Type of Device: VENTILATOR,NON-CONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington 15068 ; 7243349303
• MDR Report Key: 5246249
• MDR Text Key: 32018409
• Report Number: 2518422-2015-03966
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 561CABT
• Device Catalogue Number: 561CABT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other