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

Model Number V60

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event date: (b)(6) 2018.Date of report: 31dec2018.International udi # (b)(4).A follow-up report will be submitted once the investigation has been completed.

Event Description

The customer reported a "check vent: blower temperature high¿ occurred.There was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date rec¿d by mfr : 23jan2019.The manufacturer¿s international service technician could not confirm or duplicate the reported blower temperature issue.However, the device logs revealed the occurrence of error code "1122" (blower temperature high).The manufacturer¿s international service technician replaced the blower to address the reported problem.The unit was checked overall, run in tested, cleaned, and functionally tested and no abnormality was confirmed.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

Date rec'd by mfr: 05/18/2019.Failure analysis on the returned blower assembly shows that the blower assembly passed all testing.A high blower temperature alarm could not be duplicated.There were no faults found with the blower assembly.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: 8207289
• MDR Text Key: 131766705
• Report Number: 2031642-2018-03122
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1