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

Model Number V60 PLUS

Device Problems Human-Device Interface Problem (2949); Inadequate User Interface (2958)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Date of report: 19 aug 2021.Reporting institution phone number - (b)(6).Reporter phone number - (b)(6).

Event Description

The customer reported that a ventilator had a defective nav-ring.Patient involvement information is unknown but has been requested.No patient or user harm was reported.

Manufacturer Narrative

The device was evaluated by the customer and an international philips field service engineer (fse) who confirmed the reported issue.Patient or user involvement information is unknown and was requested from the fse.No patient or user harm was reported.Moreover, due to the context of when the issue was found being unknown, the record will be documented as if the malfunction occurred during clinical use because we do not know if the device was being set up for clinical use.We also do not know if there as a delay to patient therapy.Following the evaluation of the device, the fse replaced the front bezel to resolve the problem.The unit was then functionally tested and successfully passed all specified tests.No other anomaly was reported.Previous investigation on similar failure indicates the root cause of the nav-ring failures was determined to be liquid ingress due to the variability of the assembly process causes navigation ring to fail.

Manufacturer Narrative

Upon further investigation, the following information was received indicating that the reported issue was found outside of clinical use there was no patient was on the unit.Therefore, this complaint no longer meets reportability requirements.

• 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: 12344327
• MDR Text Key: 267333928
• Report Number: 2031642-2021-04620
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102985
• 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,Followup
• Report Date: 10/17/2021

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 Model Number: V60 PLUS
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/12/2021
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/14/2021; 08/21/2022
• Supplement Dates FDA Received: 10/18/2021; 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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