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

Model Number V60

Device Problems Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 03nov2020.

Event Description

The biomed reported to philips the unit failed electrical safety testing during preventive maintenance (pm) testing.The biomed indicated at the gas outlet port the reading was slightly out of tolerance at.3, tolerance =<.2.The remote manufacture service technician advised to clean contact at the grounding terminal block.The biomed also indicated at the oxygen (o2) inlet port reading is way out of tolerance.The remote manufacture service technician advised to remove the o2 inlet retention plate screws and remove the thread locker until the reading is in tolerance.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.

Manufacturer Narrative

After the customer reported the device malfunction, they contacted product support and requested parts id for power cord, air inlet filter and cooling fan filter.Multiple attempts were made to follow-up with the customer to obtain additional information; however, there was no response, and the contact person is no longer available.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.

• 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: 10782093
• MDR Text Key: 216339729
• Report Number: 2031642-2020-04046
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• 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
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2012
• 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