MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 02/02/2021.

Event Description

The customer reported the button on the touch screen responded poorly, so calibration was performed but the phenomenon was not improved.The unit was not in use, and there was no patient or user harm reported.

Manufacturer Narrative

G4:01feb2021.B4:25feb2021.H11:g5:k102985.H10: the field service engineer (fse) confirmed the failure through operational checking.The touchscreen calibration did not resolve the issue.The fse replaced the touchscreen, and the unit passed testing.The unit was returned to service.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

The customer reported the button on the touchscreen responded poorly, so calibration was performed but the phenomenon was not improved.The unit was not in use, and there was no patient or user harm reported.

Manufacturer Narrative

The touchscreen assembly was returned to the manufacturer for failure analysis.Visual inspection of the touchscreen assembly revealed no evidence of damage or contamination.The touchscreen was tested and found the ul_lr and ur_ll resistance were out of specification.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11267556
• MDR Text Key: 239101871
• Report Number: 2031642-2021-00393
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• 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: 12/01/2021

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 01/06/2021; 12/01/2021
• Supplement Dates FDA Received: 02/25/2021; 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2018
• 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