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

Model Number V60

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 12/17/2019.

Event Description

The customer reported o2 (oxygen) transport manifold needed to be replaced due to unsecured hose connection.The customer confirmed the reported issue.The device was not in clinical use at the time the issue was discovered, therefore, there was no patient or user harm reported.Th customer replaced the o2 transport manifold and the o2 transport manifold is working.

Manufacturer Narrative

G4: 04jun2020.B4: 06jun2020.An oxygen (o2) transport manifold was returned for analysis.A visual inspection was performed there were no signs of damage or contamination found with this unit.An investigation was performed and the this complaint was not duplicated.Once sufficient pressure was applied to the system both valves closed and remained closed without leaks.There were no leaks detected at the o2 hose.This o2 transport manifold was tested with no failures identified.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: 9489475
• MDR Text Key: 188972625
• Report Number: 2031642-2019-10909
• 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: 12/02/2019

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: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 06/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1