MAUDE Adverse Event Report: RESPIRONICS INC. RESPIRONICS S PERFOMAX SU W/EE LEAK 2 - SINGLE BIPAP MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Lot Number 46782941

Device Problem Device Slipped (1584)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/19/2021

Event Type  Injury  

Event Description

Bipap mask easily breaks and does not stay attached to the patient; staff report that clamps do not remain clamped and the mask easily pops off; this patient had this mask in use; patient confused; patient popped mask off; desaturated and required intubation.The facility has not experienced these issues with other bipap masks of other manufacturers.Fda safety report id# (b)(4).

• Brand Name: RESPIRONICS S PERFOMAX SU W/EE LEAK 2 - SINGLE BIPAP MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC. ; murrysville PA 15668
• MDR Report Key: 11265721
• MDR Text Key: 230083794
• Report Number: MW5099136
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2021

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: Health Professional
• Device Lot Number: 46782941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 108