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

Model Number V60

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 02sep2020.

Event Description

It was reported to philips by the biomed that the blower temperature was high while in use.The device was in clinical use at the time of the event.The device was swapped and there was no report of patient or user harm.A good faith effort was made and the customer confirmed on (b)(6) 2020 that therapy was completed on the patient with no issues.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The biomed advised that there was an error code (1122) in the significant event log.The biomed checked and confirmed that the air inlet filter was clean and the cooling fan was working.The rse advised the customer the problem was suspected to be an issue with the blower assembly.The rse advised the customer to change the blower assembly as per the service manual for this error code.The part information was provided to the customer to order a replacement blower assembly.A good faith effort was made to the customer who responded on (b)(6) 2020 that a new blower and cooling fan have been ordered to be replaced preventatively on this device as it is an older unit with 16k hours logged.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10486001
• MDR Text Key: 206366144
• Report Number: 2031642-2020-03129
• 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
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2010
• 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