MAUDE Adverse Event Report: PHILIPS V60 PHILIPS RESPIRONICS (REPORTED BY STAFF); BIPAP

Device Problem Low Audible Alarm (1016)

Patient Problems Death (1802); Asphyxia (1851)

Event Date 05/31/2020

Event Type  Death  

Event Description

A (b)(6) y/o female pt comes to the hosp with covid.Pt is intubated, extubated and placed on bipap in a glass door closed icu room.Pt is found pulseless and with low oxygenation.Staff reported the bipap was unplugged and the alarm was low.The serial number of the device involved in the event was not documented so we are unable to determine which device it was.Respiratory therapist staff reported that the device was a v60 bipap.Respiratory staff was not aware of the events surrounding the code blue and the device was placed back into use.Philips-respironics.

• Brand Name: V60 PHILIPS RESPIRONICS (REPORTED BY STAFF)
• Type of Device: BIPAP
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 10184055
• MDR Text Key: 196098889
• Report Number: 10184055
• Device Sequence Number: 1
• Product Code: MNT
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/01/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 62