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

Model Number V60

Device Problems Failure to Align (2522); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 28aug2020.

Event Description

The field service engineer (fse) reported power light emitting diode (led).The fse also identified the touch position was misaligned in the touchscreen.The fse confirmed the reported failure.The fse replaced the power switch overlay and the touchscreen the resolved the issues.The unit was tested and it returned to service.The unit was not in use, and there was no patient or user harm reported.

Manufacturer Narrative

G4:24nov2020.B4:29nov2020.The touchscreen assembly was returned to failure investigation (fi) for analysis.Ll electrical testing is in the specification.The customer's complaint verified; touch buttons failed to respond on the "informational message arrows." a fault is found on this returned touchscreen assembly.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: 10469166
• MDR Text Key: 207347737
• Report Number: 2031642-2020-03023
• Device Sequence Number: 1
• Product Code: MNT
• 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: 08/06/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 11/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1