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

Model Number V60 VENT, CHINA OPT: CFLEX, AVAPS

Device Problem High Readings (2459)

Patient Problems Abnormal Blood Gases (1034); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

Date of report: 06may2021.The device was reported as being in use at the time of the event on a patient.There was no adverse patient impact reported.

Event Description

It was reported to philips that the device had elevated carbon dioxide.The device was reported as being in use at the time of the event on a patient.There was no adverse patient impact reported.

Manufacturer Narrative

The service engineer (se) evaluated and concluded that the unit did not fail to meet specifications.During the device evaluation, the se found that the mask was too tight and the air leakage was too small.Problem got resolved by adjusting the mask.No repair was needed.Se reported that device was good to use.Root cause was improper mask setting.Upon internal review, this complaint has been upgraded from a product problem to a serious injury.The event of elevated carbon dioxide has been assessed as a severity 2 serious injury that necessitated medical intervention to preclude permanent impairment of a body function or permanent damage to a body.Based on the information provided, there was no device malfunction but rather unintentional use error from tight application of the mask in which the issue resolved when the mask was adjusted.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 11789491
• MDR Text Key: 249442877
• Report Number: 2031642-2021-03633
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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: Health Professional
• Device Model Number: V60 VENT, CHINA OPT: CFLEX, AVAPS
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/25/2022
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention