MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems No Display/Image (1183); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/19/2021

Event Type  malfunction  

Event Description

Patient was on a bilevel positive airway (bipap) pressure mask.The screen of the philips respironics v60 ventilator turned black with screen reading "machine inoperable." saturations dropped to 85%.Patient was immediately placed on 100% non-rebreather mask.A new bipap was placed on the patient at 100%.Patient stabilized.

• Brand Name: PHILIPS RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct; carlsbad CA 92011
• MDR Report Key: 12134475
• MDR Text Key: 260474718
• Report Number: 12134475
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/23/2021

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: No Information
• Device Model Number: V60
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA