MAUDE Adverse Event Report: RESPIRONICS INC RESPIRONICS V60 ID#12; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number 405692612

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2020

Event Type  malfunction  

Event Description

Rcp stated that the bipap screen "went out" and alarm said "vent inoperable." patient was on fio2 100% and desat to 74%.Upon emr review, there is no documentation that reflects this event on vital signs, rcp assessment, or notes.Patient's spo2 trends stable on emr at time of event reported in rl.Bipap was removed immediately, placed on non-rebreather per protocol for safety measures, and o2sats returned to baseline.Bipap machine was sequestered and red tagged.Rcp manager made aware.Patient placed on new bipap.Minimal temporary harm.Fda safety report id # (b)(4).

• Brand Name: RESPIRONICS V60 ID#12
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC
• MDR Report Key: 11228964
• MDR Text Key: 228917712
• Report Number: MW5098989
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/22/2021

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: Health Professional
• Device Model Number: 405692612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1