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

Model Number IP22

Device Problem Defective Component (2292)

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

Event Date 05/02/1954

Event Type  malfunction  

Event Description

I received the unit from a customer and saw it is defective.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION BIPAPAUTOSV
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 14288448
• MDR Text Key: 290951905
• Report Number: MW5109526
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IP22
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White