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

Model Number V60

Device Problem Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6).Date of report: 29aug2019.

Event Description

The customer reported a ventilator that "has no memory, and will not hold settings".There was no patient involvement / harm.

Manufacturer Narrative

G4: 28aug2019, b4: 01oct2019.This event was resolved in-house by the customer.There was no on-site evaluation by the manufacturer.The customer reported that the setting issue was resolved by a calibration of the touch screen.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: 8944717
• MDR Text Key: 177369106
• Report Number: 2031642-2019-07541
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1