MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number NDX500S15

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging that a refurbished dreamstation auto cpap device received by patient a on (b)(6) 2023 contained data on (b)(6) 2023 from patient b.The data from patient b was reported to be transferred to patient a and therefore is incorrect.No patient injury or harm has been reported at this time.In addition, a request has been made for additional information.The manufacturer is currently investigation this complaint; however, the device examination has not yet begun because the device has not yet returned to the manufacturer for evaluation.As part of the complaint handling process, the manufacturer will make attempts to retrieve the device for investigation.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 17755925
• MDR Text Key: 323507721
• Report Number: 2518422-2023-23151
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NDX500S15
• Device Catalogue Number: NDX500S15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1