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

Model Number V200

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

It was reported that during use, the ventilator shut off and went inoperable.The customer found several error codes in the ventilator diagnostic logs.The patient was not harmed or injured as a result of the reported event.

Manufacturer Narrative

Date of report: 30may2019.Date rec¿d by mfr: 03may2019.Date of event (b)(6) 2019.Reportedly, during use the ventilator made a noise that was not normal, then shut down.The patients fraction of inspired o2 (fio2) was at 50% the philips field service engineer (fse) evaluated the ventilator and found the ventilator operated on back up battery but would not operate when plugged into alternate current (ac) power.The fse replaced the power supply and the ventilator powered up as normal on ac power, passed all required testing and is back in service.The fse reviewed the ventilator event log and there were no error codes.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

(b)(6) 2019; the patient was removed from the ventilator and manually ventilated before being placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.Additional information has been requested.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: 8557728
• MDR Text Key: 143469816
• Report Number: 2031642-2019-02514
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 158