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

Model Number V60

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 01mar2021.

Event Description

The customer reported that "battery failed" alarm had sounded.The unit kept operating 14:30.The sales rep brought an alternative v60 to the hospital.The faulty v60 had already been removed from the patient.The unit was in clinical use, however there was no patient harm.

Manufacturer Narrative

G4:18feb2021.B4:17mar2021.The field service engineer (fse) could not duplicate the reported failure.The (fse) confirmed the error code in the diagnostic error report (drpt).The field engineer advised the lithium-ion battery needs replacement.A quote was sent to the customer.Further servicing is pending customer reply.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

G4:07apr2021.B4:26apr2021.The field service engineer (fse) could not duplicate the reported failure.The fse confirmed the error code in the diagnostic error report (drpt).The event log revealed that "check vent: battery failed" had occurred.The fse also identified power on/off light emitting diode (led) was unable to illuminate.The fse replaced the lithium-ion battery and the phenomenon was resolved.The unit was tested and it was returned to service.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

The unit was in clinical use.The unit was swapped out; there was no patient or user harm reported.The customer used an old battery on the unit, which eventually failed.The unit had to be swapped out for another one.The battery had a manufacture date of 8/22/2012, which indicates it was over 5 years old.The battery was past its life expectancy, and so this was a user error.The battery has reached shelf-life as specified by the manufacturer.

• 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): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11396718
• MDR Text Key: 242348602
• Report Number: 2031642-2021-00775
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/24/2021

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 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: 02/01/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 02/01/2021; 02/01/2021; 11/17/2021
• Supplement Dates FDA Received: 03/18/2021; 04/26/2021; 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.