MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number V200

Device Problem Inadequate User Interface (2958)

Patient Problem Dyspnea (1816)

Event Date 12/07/2020

Event Type  Injury  

Event Description

Philips received information that the v200 ventilator experienced an issue during therapeutic/clinical use where the settings were unable to be titrated to patient needs due to an undefined user interface issue.The device was in therapeutic/clinical use at the time of the noted event.Information provided by the reporter states that due to the inability to adjust clinical settings, the patient was noted to have experienced difficulty breathing which required medical intervention via device swap.No further harm or injury was noted.

Manufacturer Narrative

B4: 21aug2021.Multiple good faith efforts have been made by the device manufacturer to obtain further contextual information regarding the alleged malfunction and event.However, due to lack of further communication received from the customer, device evaluation, resolution, and root cause of malfunction could not be ascertained.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 11566764
• MDR Text Key: 242377680
• Report Number: 2031642-2021-03114
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V200
• Device Catalogue Number: 1060264
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/24/2021
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR