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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/29/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging the patient the patient has been using their device for about a year in may and after surgery their o2 levels were dropping too low, even with the cpap.The patient's physician order another sleep study which found that the patient needed high pressure to keep their o2 levels up.The first night with their machine the new pressure the patient's lips were blowing open and their mouth got dry.They switched masks and was awoken by the leaks.The mask rubbed the bottom of their nose raw.At this time, no further investigation can be performed.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

The manufacturer previously reported and event alleging the patient the patient has been using their device for about a year in may and after surgery their o2 levels were dropping too low, even with the cpap.The patient's physician order another sleep study which found that the patient needed high pressure to keep their o2 levels up.The first night with their machine the new pressure the patient's lips were blowing open and their mouth got dry.They switched masks and was awoken by the leaks.The mask rubbed the bottom of their nose raw.The previous report incorrectly captured the reported event as an adverse event, required intervention as outcomes attributed to ae and type of reported complaint as serious injury.The event is a product problem.The form's box b: adverse event or product problem and box h: device manufacturers have been updated.

• Brand Name: PHILIPS CPAP DEVICE
• 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: 17848485
• MDR Text Key: 324657531
• Report Number: 2518422-2023-25057
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention