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

Model Number V200

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09jun2020.

Event Description

It was reported that after replacing the power supply there was an odor.There was no patient involvement.The customer troubleshot with technical support.The customer reported that the unit had been in storage and that the unit would originally not run on alternating current (ac) or battery, it would not indicate it was charging.The customer then replaced the power supply and the unit has a 'warm odor'.The customer was advised to inspect the unit internal for any thermal damage.

Manufacturer Narrative

G4: 15jul2020 b4: (b)(6) 2020 upon a follow-up, the customer indicated that the odor coming from the power supply went away, and there was no further issue with the odor.The customer stated having another problem with the unit with the safety valve failing during the extended self test (est).The customer will call back when available to troubleshoot with technical support.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

G4: 17aug2020.B4: 18aug2020.Multiple attempts were made to obtain information on the repair/service of the device but have been unsuccessful.A supplemental report will be submitted if new data is received.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: 10135119
• MDR Text Key: 195083247
• Report Number: 2031642-2020-02022
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• 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: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1