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

Model Number V60 PLUS

Device Problems Smoking (1585); Unexpected Shutdown (4019)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting address state: (b)(6).An emergency part returns has been requested, and root cause analysis will be established based on the results of the investigations.

Event Description

The customer (institutional telemedicine technician) reported that during intervention with the v60 ventilator, the equipment turned off after an internal short circuit generating smoke.A patient of unknown age and gender who was an inpatient in the institutional intensive care unit (icu) was prescribed v60 ventilator therapy (software version not available) for an unknown indication.On (b)(6) 2022 during clinical use and while the device was being worked on for an unspecified reason, the patient¿s nurse observed a spark and smoke from the system, with the cable of the plug smoldered in the connector of the equipment.The smoke sensors were triggered and tripped the electrical protection.The patient was removed from the device, and as a precautionary measure, manual ventilation was administered until the device could be replaced with another unit.There was no patient harm or injury incurred.The device was evaluated by the institutional biomedical engineer with the assistance from a philips remote service engineer (rse).They have contacted the customer, who indicated that during a ventilator intervention, an internal short circuit occurred in the equipment causing the equipment to turn off.Burnt connector and power cables were observed, with the cable stucked to the ac input connector.The ac inlet was replaced, and operational tests were performed in which the system did not meet the full specification for the performed service and is returned to use with limitation as accepted by the customer.The unit was repaired on (b)(6) 2022 and is working correctly.

Manufacturer Narrative

Upon internal review, this case has been downgraded from a serious injury to a product problem as there was no harm or injury incurred by the patient.The type of ventilation work being performed at the time of the event was not provided by the customer.A patient of unknown age and gender who was an inpatient in the institutional intensive care unit (icu) was prescribed v60 ventilator therapy (software version not available) for an unknown indication.On (b)(6) 2022 during clinical use and while the device was being worked on for an unspecified reason, the patient¿s nurse observed a spark and smoke from the hospital fire prevention system (smoke alarm which activates the fire alarm), with the cable of the plug smoldered in the connector of the equipment.The smoke alarm was triggered and the main power line protection powered down which detected a short circuit.The patient was removed from the device, and as a precautionary measure, manual ventilation was administered until the device could be replaced with another unit.There was no patient harm or injury incurred.As previously stated, the unit was repaired on 13-may-2022 and is working correctly.No other information was provided.The system meets the specification for the performed service and is returned to use.

Manufacturer Narrative

A philips failure investigation (fi) engineer indicated that due to the heat related physical damage no further testing will be performed by rica fi.These parts will be sent out for external analysis and this report will be updated when the external analysis is provided.

• 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: 14403420
• MDR Text Key: 292732721
• Report Number: 2031642-2022-01309
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K102985
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 PLUS
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/14/2022
• Supplement Dates Manufacturer Received: 05/29/2022; 07/29/2022
• Supplement Dates FDA Received: 06/24/2022; 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2020
• 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
• Patient Outcome(s): Required Intervention