MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. RESPIRONICS V200; VENTILATOR

Model Number V200 ESPRIT

Device Problem Mechanical Problem (1384)

Patient Problems Death (1802); Pulmonary Edema (2020)

Event Date 06/29/2019

Event Type  Death  

Event Description

Ventilator alarmed at 2040.Nurse and respiratory therapist went into the room and ventilator was in electronic failure.The pt was bagged by the rn until the respiratory therapist could obtain a new ventilator.The pt was transferred to the acute care hospital.

• Brand Name: RESPIRONICS V200
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC. ; carlsbad CA
• MDR Report Key: 8965695
• MDR Text Key: 156734310
• Report Number: 8965695
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/30/2019,08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V200 ESPRIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Distributor Facility Aware Date: 06/29/2019
• Device Age: 9 YR
• Event Location: Other
• Date Report to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2019
• 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: 0
• Patient Outcome(s): Death
• Patient Age: 40 YR
• Patient Weight: 46