MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC V60; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Device Problems Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477); Patient Problem/Medical Problem (2688)

Event Date 03/06/2019

Event Type  malfunction  

Event Description

While adjusting patient's bipap mask, a strange noise was heard from the mask.Patient began to complain that they could not breath and immediately desaturated.Fogging occurred in the mask and an alert on the bipap stated the patient was rebreathing their co2 and there was no leak.Patient quickly desaturated to the low 60%.Got a new mask and placed the patient on a heated high flow at 100% o2 and 601pm.Elbow on the mask was changed because exhalation could not be felt.Placed patient back on the bipap and was able to ventilate the patient and o2 saturations recovered.

• Brand Name: V60
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 9543050
• MDR Text Key: 173465693
• Report Number: 9543050
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/20/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 67