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

Model Number V60

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.(b)(6)2020.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.

Event Description

The customer reported the following errors: 35 v fault, ventilator restarted due to anomalies detected during operation, backup alarm failed, 35 v supply failed, and auxiliary alarm supply failed.There was no patient involvement.

Manufacturer Narrative

The device was not being used for medical treatment; no further details were provided regarding the event.No patient or user harm was reported.

Manufacturer Narrative

The unit was in clinical use at the time of the event.No patient or user harm reported.Customer reported a code of 1104-backup alarm failed.During technical assistance, the remote service engineer (rse) verified with customer that the following codes were logged (codes 1101-ventilator restarted due to anomalies detected during operation, 1104-backup alarm failed, 111b-35v supply failed, 1115-auxilliary alarm supply failed).The customer was then advised to replace the cpu board (p/n 1123932 / 453561535741 (software 2.10)).The rse also spoke with the customer regarding the serial number and power on hrs reload, while using a teraterm.It was also noted that the rse was advised to call back for option codes.It was reported that the cpu board was replaced, and the customer was provided with option codes for cflex, avaps, and ramp.Multiple good faith efforts (gfe) were performed to obtain information regarding the the operational status of the device; however, no response was provided.

Manufacturer Narrative

H11:h6: patient information: the device was being used for medical treatment; no further details were provided regarding the event.No patient or user harm was reported.

Manufacturer Narrative

The device was being used for medical treatment, and the patient was transferred to a different ventilator; no further details were provided regarding the event.No patient or user harm was reported.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11022847
• MDR Text Key: 222320366
• Report Number: 2031642-2020-04598
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/22/2021

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 08/04/2021; 09/08/2021; 09/22/2021; 10/27/2021
• Supplement Dates FDA Received: 09/03/2021; 09/08/2021; 10/20/2021; 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1