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

Model Number V60

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Serial number unknown.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the battery did not function on delivery.There was no patient involvement.

Manufacturer Narrative

Order management medical supplies confirmed the reported battery issue.Replacement battery was sent to customer for arrival on (b)(4) 2017 on (b)(4).During further investigation (fi), a visual inspection of the li-ion battery assembly revealed no signs of damage or contamination.The battery was installed in an fi test ventilator.The ventilator started up in normal ventilation (ac and battery connected) and deliver breaths.The ac was disconnected and the ventilator continued to operate on battery only without any errors occurring.The ventilator was started up in diagnostic mode and the battery voltage and current were read.The displayed battery voltage was 14.58v and the battery was being charged with 2.66a current.The internal battery test (pvt test 11) was executed that the battery passed.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is no relationship of the device to the reported problem.The customer returned battery pack was installed in an fi ventilator.The ventilator would start up and run without errors occurring and was able to run on battery only.The battery was partially discharged.After charging the battery fully the battery pv test was executed and passed.No failure was found.

• 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; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7154392
• MDR Text Key: 96221949
• Report Number: 2031642-2017-03923
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• 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: 02/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1