MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number V200

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 15april2019.A follow-up report will be submitted once the investigation has been complete.

Event Description

The customer reported that the machine is turning off automatically.There was no patient involvement.Event date not specified, estimate used.

Manufacturer Narrative

Date rec'd by mfr: 06may2019.The customer confirmed the reported system shut-down issue.The customer reseated the power supply cable connections.The customer kept the ventilator under observation.System as of now is working ok.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: V200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8515434
• MDR Text Key: 142053041
• Report Number: 2031642-2019-02234
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1