MAUDE Adverse Event Report: DEVILBISS HEALTHCARE, LLC. CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number DV51D-120 REV G

Device Problems Material Discolored (1170); Material Puncture/Hole (1504); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 10/30/2022

Event Type  malfunction  

Event Description

I noticed black debris in my cpap (continuous positive airway pressure) hose.I took the machine apart and found a hole was torn apart near the circulation pump.The cpap was a devilbiss intellirap or dv51d.The foam insulation had turned into a black sticky tar like substance.Fda safety report id (b)(4).

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): DEVILBISS HEALTHCARE, LLC.
• MDR Report Key: 15864994
• MDR Text Key: 304372585
• Report Number: MW5113485
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DV51D-120 REV G
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White