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

Model Number DE462S

Device Problem Degraded (1153)

Patient Problems Cyst(s) (1800); Cough (4457); Renal Impairment (4499)

Event Date 09/20/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging that a continuous positive airway pressure (cpap) device's sound abatement foam became degraded.The patient has indicated being hospitalized for kidney problems with continued treatment, development of a cyst and an on-going cough.It is unknown what medical intervention was required by the patient.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported that a continuous positive airway pressure (cpap) device's sound abatement foam allegedly became degraded.The patient has indicated being hospitalized for kidney problems with continued treatment, development of a cyst and an on-going cough.It is unknown what medical intervention was required by the patient.The device was returned to the manufacturer quality product investigation laboratory for further investigation.During the initial visual investigation of the exterior of the device, the manufacturer found evidence of minor wear and tear around the display.The manufacturer also found evidence of minor corrosion to component ui.The manufacturer applied power to the device and found the device to operate without issue or error codes.The device was disassembled for internal visual inspection.The manufacturer found mild dust contamination throughout the device.The manufacturer found dust contamination and smoky odor to the blower and on the impeller.Flecks of a dark brown contaminant were found at the 90° elbow immediately after the blower seal which had the distinct odor of tobacco.Microscopic review showed the contaminant appears primarily tar-like with a thinner oily liquid at the base.Sound abatement foam did not appear to have degraded and returned to original shape when compressed.The manufacturer concludes there is no evidence of foam degradation within the device.The device operated as designed.Correction to section b2.

• Brand Name: REMSTAR PRO C-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 15206 ; 2673970028
• MDR Report Key: 12573430
• MDR Text Key: 274752487
• Report Number: 2518422-2021-04666
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030220
• UDI-Public: 00606959030220
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DE462S
• Device Catalogue Number: DE462S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization