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 Inadequate User Interface (2958)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported to philips unit with a touchscreen issue.It is unknown if the device was in clinical use at the time of the event at this time; however, there was no report of patient or user harm, and a delay in therapy was not reported due to this failure.A failure in the touch panel was confirmed.The unit was calibrated, and the phenomenon was duplicated.The reproductivity was confirmed on-site and in the sales office.

Manufacturer Narrative

The patient was moved to an alternate ventilator as a result of the reported failure.No patient harm or injury was noted.

Manufacturer Narrative

The device was in use at the time the issue was discovered, there was no patient or user harm reported.A delay in therapy was not reported due to this failure.The device was checked but the reported issue was unable to be confirmed.The touchscreen was replaced to prevent recurrence.The unit was checked overall, cleaned, and run-in and functionally tested.The device has software version 2.30.A touch screen assembly was returned for analysis.Visual inspection of the touch screen assembly revealed no evidence of damage or contamination.An investigation was performed, and all electrical and touchscreen testing is in specification, no fault was found on the returned touchscreen.

• 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: 13114294
• MDR Text Key: 287555247
• Report Number: 2031642-2021-05909
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 12/06/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 03/14/2022; 03/14/2022
• Supplement Dates FDA Received: 04/11/2022; 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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