MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTOA-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DS560HS

Device Problems Degraded (1153); Sparking (2595); Electrical Overstress (2924); Data Problem (3196); Noise, Audible (3273)

Patient Problems Sore Throat (2396); Cough (4457)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient alleges dry throat, "waking up coughing in the morning", device being noisy and chip not recording anymore.The device sparks once in a while when it is plugged into an outlet and it also uses too much power.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer's product investigation laboratory.The device powered on and airflow was confirmed.During exterior investigation, it was observed that the base unit did not have a ui knob present.Unknown dust/dirt contamination, unknown oily residue on device surfaces, damaged base unit¿s rubber feet were also observed.Care orchestrator data could be collected from device using a standard sd card.Internal investigation of base unit found unknown dust/dirt contamination throughout the device internals.Oily residue throughout device internals, with a majority of the concentration and pooling of the oil-like substance on outlet side panel area where the humidifier base would mate, was observed.Blower grommet was not seated in blower housing which suggests user tampering.Sound abatement foam showed collection of dust and unknown fibers in areas.Sound abatement foam did not appear to have degraded and returned to original shape when compressed.Evidence of sound abatement foam degradation/breakdown was not observed in this device.The device logs were downloaded which found 2 errors and 10754.5 blower and 10706.2 therapy hours.Care orchestrator data shows the patient had a compliance rate of (b)(4) and used the system one humidification setting 2 during the most recent 90 days of use.The unknown dust/dirt contamination, fibers, and unknown oil like residue found on the blower casing/impeller and blower box was inconsistent with degraded sound abatement foam contamination.The presence of contamination throughout the airpath suggests a source external to the device.The manufacturer can confirm that the sd card reader functions.The ¿sparking¿ observed was most likely due to the unknown substance covering the base unit, but it does not confirm this phenomenon as stated in complaint.The complaint of noise and presence of contamination in the airpath could not be confirmed.The manufacturer confirms that there was no evidence of sound abatement foam degradation/breakdown observed in the base unit.

Manufacturer Narrative

The patient provided the manufacturer with two serial numbers: (b)(6) and (b)(6).

Manufacturer Narrative

The manufacturer previously reported the (device) problem code grid with incomplete coding which is corrected in the current report.

• Brand Name: REMSTAR AUTOA-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17879262
• MDR Text Key: 325024784
• Report Number: 2518422-2023-25067
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005891
• UDI-Public: 00606959005891
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS560HS
• Device Catalogue Number: DS560HS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2023
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1