MAUDE Adverse Event Report: PHILIPS RESPIRONICS RESPIRONICS BIPAP MASK; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number AF131

Device Problems Break (1069); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

Patient was experiencing low spo2 and required the bipap.Placed the mask on the patient and the "seal" was broken at the whisper valve.Replaced nasal cannula and called fellow respiratory therapists to bring a new mask.Replaced the defective mask with a new mask with no incident.

• Brand Name: RESPIRONICS BIPAP MASK
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS RESPIRONICS; 174 tech center drive, suite 200; mount pleasant PA 15666
• MDR Report Key: 7391567
• MDR Text Key: 104174731
• Report Number: 7391567
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF131
• Device Lot Number: AP17109
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 114