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

Model Number DS460HS

Device Problem Degraded (1153)

Patient Problem Rash (2033)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

This notification is being reviewed due to a user of a remstar pro c-flex device with an alleging getting rashes all over the body.There was no serious patient harm or injury.There was no medical intervention reported.The device was not returned to the manufacturer for evaluation.There was no patient harm or injury associated with this notification and no increased risk to the intended user.This device meets ul and iec requirements for flammability.Based on the information available, no mdr will be filed.If upon evaluation of the device a reportable issue/malfunction is identified, this decision will be re-evaluated using the date of the repair evaluation as the "become aware" date if a reportable issue/malfunction is identified.

• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19177312
• MDR Text Key: 341018516
• Report Number: 2518422-2024-22256
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005839
• UDI-Public: 00606959005839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091319
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS460HS
• Device Catalogue Number: DS460HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2013
• 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