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

Model Number 312118

Device Problems Device Alarm System (1012); Connection Problem (2900)

Patient Problem Death (1802)

Event Date 08/07/2020

Event Type  malfunction  

Event Description

Call light system/audio alarm system that detects bipap not connected to patient, did not alarm in room nor, did it alarm at nursing station.Patient coded and after 30 minutes of resuscitation efforts expired.Patient with multiple comorbidities unable to attribute event as cause of patient's outcome.Fda safety report id# (b)(4).

• Brand Name: RESPIRONICS BIPAP DISPOSIABLE CIRCUIT
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC. ; murryville PA 15668
• MDR Report Key: 10448013
• MDR Text Key: 204355113
• Report Number: MW5096217
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2020
• 2 Devices were Involved in the Event: 1 2

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: 312118
• Device Lot Number: 200416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 66 YR