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

Model Number V60

Device Problems Device Alarm System (1012); Unexpected Shutdown (4019)

Patient Problem No Code Available (3191)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Initial review of this case suggests the ventilator shut down and did not alarm while in patient use as the nurse was tending to the patient.The customer indicated there was a delay in patient treatment however there is no indication that the patient was injured as a result of this event.Further information is being requested from the customer in order to create an mdr summary.

Manufacturer Narrative

Date rec¿d by mfr: 23may2019.Date of report : 05jun2019.The philips principal engineer reviewed the diagnostic logs (drpt) and the information suggests the 35v power supply failed.A complete evaluation of the ventilator is pending.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 : 28jun2019.Date of report : 30jul2019.The philips principal engineer replaced the power management board and completed performance verification on the ventilator.The ventilator is within factory specifications and is now back in clinical use.The alleged defective power management board will be returned to philips for failure investigation.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: 8545476
• MDR Text Key: 142941750
• Report Number: 2031642-2019-02404
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 04/09/2019; 04/09/2019
• Supplement Dates FDA Received: 06/05/2019; 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR