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

Model Number V60

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

The customer contacted philips to get the part information for a replacement touchscreen.The biomed reported that he kept having to calibrate the touchscreen.The device was not in use at the time of the event.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The rse provided the part information for a replacement touchscreen.

Manufacturer Narrative

G4: 05nov2020.B4: 05nov2020.Multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.A review of service history found no parts were ordered or service requested and the case was closed.If additional information is later obtained, a supplemental report will be submitted.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: 10673362
• MDR Text Key: 212513898
• Report Number: 2031642-2020-03691
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1