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

Model Number V60

Device Problem Component Falling (1105)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

The customer reported that a castor failed and the cart fell and injured the user.During follow-up, the customer reported that the user did not require any medical intervention.

Manufacturer Narrative

No further information was made available after several attempts to acquire more information on the device.If further information is received a follow-up report will be submitted.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6857499
• MDR Text Key: 85945123
• Report Number: 2031642-2017-02907
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

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: Respiratory Therapist
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 08/17/2017
• Supplement Dates FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention