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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: (b)(4) 2019.International udi: (b)(4).The philips field service engineer replaced the oxygen solenoid valve to resolve this issue.The unit passed the performance verification tests when the repair was complete.

Event Description

Philips field service engineer (fse) reports o2 concentration failure.There was no patient or user harm reported.The event date was not specified; estimate used.

Manufacturer Narrative

Date rec'd by mfr: 10may2019.Date of report: 12jun2019.The oxygen solenoid was received for evaluation.Excessive lubricant on the solenoid body was noted during visual inspection.After testing, it was determined that the reported failure was due to the leaking solenoid that had debris between sealant o-ring and body.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: 8350294
• MDR Text Key: 136733827
• Report Number: 2031642-2019-00978
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1