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) 2020.Date of report: 21sep2020.

Event Description

The customer reported a ventilator with a touchscreen calibration failure.There was no patient involvement or harm.

Manufacturer Narrative

G4: 03nov2020 b4: (b)(6) 2020 the remote service technician recommended ordering and replacing v60 touchscreen to the customer.The customer advised the remote service technician to close the case, multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response if additional information is later obtained, a supplemental report will be submitted.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.1.Thursday, (b)(6), 2020 12:09 pm emailed (b)(6); 2.Thursday, (b)(6), 2020 9:22 pm emailed (b)(6)@ (b)(6); 3.Tuesday, (b)(6), 2020 12:57 pm emailed (b)(6); 4.Thursday, (b)(6), 2020 called (b)(6) left a voice message 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: 10560626
• MDR Text Key: 208336140
• Report Number: 2031642-2020-03360
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1