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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 20may2019.A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported touchscreen issues.No patient or user harm was reported.

Manufacturer Narrative

Date rec¿d by mfr: 23jun2019.Date of report: 26aug2019.The manufacturer's field service engineer confirmed the reported problem.The manufacturer's field service engineer replaced the touch screen assembly to correct this reported event.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.

Manufacturer Narrative

Mfr received date: 30 aug 2019.The touch screen assembly was returned to the manufacturer's failure investigation lab for evaluation.Visual inspection of the touch screen assembly revealed no evidence of damage or contamination.The touch screen assembly was installed into the fi test ventilator to verify and test its functional integrity.From testing, it was determined that the ul_lr and ur_ll resistance and resistance ratio were out of specifications.Fault was found on this returned touch screen 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: 8625549
• MDR Text Key: 145743017
• Report Number: 2031642-2019-03097
• 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,Followup
• Report Date: 04/30/2019

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 04/30/2019; 04/30/2019
• Supplement Dates FDA Received: 08/26/2019; 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1