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

Model Number DSX700H11

Device Problems Corroded (1131); Degraded (1153)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

A device was returned to a third party service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device at the third party service center, the device was visually inspected and visible foam particles were observed.The third party service center found the evidence of contamination and also found contamination of foam particles inside the blower kit.Additionally, the patient¿s complaint was confirmed and the device was corroded.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

H3 other text : device serviced by a third-party service center.

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 the power connector of the unit was corroded.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 (RESPIR ATOR)
• 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: 18538378
• MDR Text Key: 333171929
• Report Number: 2518422-2024-03389
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: Other
• Device Model Number: DSX700H11
• Device Catalogue Number: DSX700H11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2016
• 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