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

Model Number DS220HS

Device Problem Degraded (1153)

Patient Problem Pulmonary Embolism (1498)

Event Date 07/21/2021

Event Type  Injury  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient alleges a pulmonary embolism in the left and right lung.The patient was hospitalized for 14 days - 6 days in the icu.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer.

• Brand Name: REMSTAR SE
• 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 15208 ; 4125423300
• MDR Report Key: 17398490
• MDR Text Key: 319800193
• Report Number: 2518422-2023-17000
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959012493
• UDI-Public: 00606959012493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130077
• 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

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS220HS
• Device Catalogue Number: DS220HS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization