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

Model Number V60

Device Problems Overheating of Device (1437); Blocked Connection (2888)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

It was reported to philips that a patient rolled onto the circuit, causing occlusion alarms, and the blower overheated.This event was reported to have occurred while in patient use.Delay of treatment was noted.The customer spoke with a philips remote service engineer (rse).The rse discussed the circuit occlusion error and the blower overheat errors with the customer.The customer inquired what was needed to certify the device was safe to use.The rse suggested requesting a field service engineer (fse) perform a performance verification test (pvt) on the device.Following the evaluation of the device, the customer tested the device and placed it back in service.Based on the information provided, the reported problem occurred due to unintentional user error as the patient rolled onto the circuit.Investigation has concluded that the device functioned as intended and there was no deficiency or malfunction.

Manufacturer Narrative

The patient was placed on an alternate vent.There was no patient harm.Customer provided an update that there was no delay to treatment.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14644894
• MDR Text Key: 294024766
• Report Number: 2031642-2022-01544
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2022
• Date Device Manufactured: 01/04/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1