MAUDE Adverse Event Report: PHILIPS RESPIRONICS REMSTAR AUTO P-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number FR568S

Device Problem Degraded (1153)

Patient Problems Fluid Discharge (2686); Cancer (3262); Eye Pain (4467); Nodule (4551)

Event Date 04/25/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused kidney cancer in (b)(6) 2019, lung nodules in (b)(6) 2020, sneezing, sputum production and eye pain.The patient did report to receive medical intervention and had a right total nephrectomy and immunotherapy.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: REMSTAR AUTO P-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS; 1001 murry ridge ln; 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: 14376935
• MDR Text Key: 291519044
• Report Number: 2518422-2022-18158
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030978
• UDI-Public: 00606959030978
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FR568S
• Device Catalogue Number: FR568S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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; Required Intervention