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

Model Number DS460S

Device Problem Degraded (1153)

Patient Problems Pulmonary Edema (2020); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer received new and relevant information on 09/12/2022 patient alleging fluid on the lungs related to a cpap device's sound abatement foam.Appropriate code has been added in h6 section.

Manufacturer Narrative

The manufacturer previously submitted mdr with incorrect sections b1, b2, h1, h6.Corrections to previous mdr are made in this report as follows.Section b1 was corrected to adverse event (product problem was checked in initial mdr) section b2 was corrected to other serious or important medical events.(previously it was blank) section h1 was changed from malfunction to serious injury.In this report, health effect - impact code has been updated or corrected.

• 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: 15104038
• MDR Text Key: 303276021
• Report Number: 2518422-2022-65280
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005822
• UDI-Public: 00606959005822
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS460S
• Device Catalogue Number: DS460S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 01/12/2024
• Supplement Dates FDA Received: 12/14/2022; 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2013
• 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