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

Model Number V60

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 28jul2020.

Event Description

The v60 unit was sent to the international service center for routine periodic maintenance.There was no patient involvement.The manufacturer¿s international service technician during device servicing identified the touch screen had a misalignment between touch position and response position.Calibration was performed, but the issue was not fixed, so the touch screen was replaced then it was fixed.No other issues were identified.The device successfully passed performance verification testing.The device is ready to be sent back to the customer for patient use.

Manufacturer Narrative

G4:03dec2020.B4:05dec2020.Visual inspection of the returned defective touchscreen assembly revealed no evidence of damage or contamination.The touch screen assembly was installed into an failure investigation (fi) test ventilator in an attempt to duplicate the reported problem of touchscreen failure.The fi investigation determined that the ul_lr and ur_ll resistance were out of specification which caused the touchscreen to fail.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.

• 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
• MDR Report Key: 10335614
• MDR Text Key: 201555307
• Report Number: 2031642-2020-02538
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1