MAUDE Adverse Event Report: RESPIRONICS, INC. RENTAL-DREAMSTATION CELLULAR MODEM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number R100621C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2024

Event Type  Death  

Event Description

The manufacturer received information alleging a patient with a dreamstation auto cpap device passed away.There was no allegation that the device contributed to the death.Additional information has been requested regarding the details of the reported death.The manufacture's investigation is ongoing.A follow up report will be submitted when the manufacture's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: RENTAL-DREAMSTATION CELLULAR MODEM
• 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: 19211907
• MDR Text Key: 341361713
• Report Number: 2518422-2024-23737
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: R100621C
• Device Catalogue Number: R100621C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death