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

Model Number IN461S

Device Problem Degraded (1153)

Patient Problem Solid Tumour (4552)

Event Date 02/11/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to develop tumor in lungs.The medical intervention that the patient received in response to the event is currently unknown.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• Brand Name: REMSTAR PRO C-FLEX+
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13570656
• MDR Text Key: 286432717
• Report Number: 2518422-2022-05629
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030251
• UDI-Public: 00606959030251
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K113068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IN461S
• Device Catalogue Number: IN461S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• 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