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

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

While in radiology department, respiratory therapist (rt) went to get new tanks.Rt placed one tank in holder and attached to v60 and placed other tank in holder.Rt noted screen on v60 went black and had words in white stating "cdc.Manually bagged." new ventilator obtained to continue assisting patient with breathing.

• Brand Name: PHILIPS RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 6501 living place; pittsburgh PA 15206
• MDR Report Key: 14619229
• MDR Text Key: 293459784
• Report Number: 14619229
• 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: 04/29/2022,04/28/2022

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 Model Number: V60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 95 KG