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

Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+

Device Problem Human-Device Interface Problem (2949)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

It was reported to philips a touched position on the touchscreen was observed to be out of alignment.There was no patient involvement or harm.This event was reported to have occurred during periodic maintenance (pm).The philips field service engineer (fse) observed the issue.Touchscreen calibration was performed but the issue was not resolved.Following the evaluation of the device, the fse replaced the touchscreen to resolve the problem.The unit was then functionally tested and successfully passed specified tests.No other abnormality was observed.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

The touchscreen was returned to failure investigation.The resistance measurements and resistance ratio test passed.The reported complaint of touchscreen failure was not duplicated.There was no fault found on the returned touchscreen assembly.

• 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: 14084593
• MDR Text Key: 289083939
• Report Number: 2031642-2022-00935
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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