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

Model Number DSX700H11

Device Problems Corroded (1131); Scratched Material (3020)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device was evaluated by a 3rd party service center.

Event Description

The manufacturer received information in relation to a dreamstation auto bipap.There was no report of serious or permanent harm or injury.During evaluation of the device at a third-party service center, bottom enclosure was found to be damaged and ui panel was scratched.The device was found to be functional.Connector oxide contamination was detected.The device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

The manufacturer received information in relation to a dreamstation auto bipap unit.The device was returned to a third party service center.During visual inspection of the device, it was determined connector oxide contamination.Additionally, cosmetic defect found as bottom enclosure damage and scratched ui panel during the device evaluation.Device was scrapped at customer's request.Analysis of past events has not indicated an adverse event has occurred due to corrosion.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.Additionally, the risk file indicates that corrosion will not substantially affect the performance of the device.This complaint is considered not reportable.

• Brand Name: DREAMSTATION AUTO BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18211708
• MDR Text Key: 329039225
• Report Number: 2518422-2023-31785
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022539
• UDI-Public: 00606959022539
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSX700H11
• Device Catalogue Number: DSX700H11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1