MAUDE Adverse Event Report: RESPIRONICS INC. RESPIRONICS V60; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems No Display/Image (1183); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

Patient's bipap was sounding a high priority alarm.The nurse went into the patient's room and the bipap read "vent inoperative" on a black screen.Rt (respiratory therapist) notified and the bipap was exchanged.During interim, the patient was placed on a nrb (non-rebreather) and oxygen sats remained above 93%.The machine was taken to biomed.Manufacturer response for ventilator, respironics v60 (per site reporter).No response.

• Brand Name: RESPIRONICS V60
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 6501 living place; pittsburgh PA 15206
• MDR Report Key: 16466734
• MDR Text Key: 310515602
• Report Number: 16466734
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/17/2023,02/14/2023

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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2023
• Device Age: 3 YR
• Date Report to Manufacturer: 03/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male
• Patient Weight: 63 KG