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

Model Number V60

Device Problem Excessive Heating (4030)

Patient Problem Respiratory Arrest (4461)

Event Date 11/26/2021

Event Type  Death  

Manufacturer Narrative

The device has been evaluated by a philips authorized service provider.Diagnostic reports were retrieved from the device confirming the date, time, and malfunction.The v60 ventilator has been inspected and evaluated by a philips authorized service provided with the determination being made that the device will require replacement of the blower motor, motor controller printed circuit board (mc-pcba).Further final disposition is pending replacement and repair of the unit.

Event Description

Philips received notification from an institutional biomed that while in clinical use and providing therapy, the v60 ventilator experienced a 1002 error code (blower temperature too high) and had gone into an inoperative state.The device was in clinical and therapeutic use at the time of the event.On (b)(6) 2021 at approximately 1105 the v60 ventilator experienced a 1002 error code (blower temperature too high) and had gone into an inoperative state.The institutional respiratory therapist was present to witness the occurrence, noting a black display screen with audible and visual alarms.Patient reidentified demographics were not provided.The patient primary diagnosis was covid-19 positive with noted poor prognosis and do not intubate (dni) status.During the event in question, the patient went into respiratory arrest and advanced cardiovascular life support (acls) was administered.The patient was unable to recover and subsequently expired.

Manufacturer Narrative

A philips field service engineer (fse) verified the significant event log of 1122 error code ( blower temperature high).The significant event log recorded the following diagnostic codes of 1002 and 1122 on 23-nov-2021: 1002,11:05.17am,11-23-2021, cbitoverheat1iblowervio 1162; and 1122,09:00.50am,11-23-2021,cbittemphigherrorblower 967.The fse replaced the blower and mc-pcba and performed all required tests as per the v60 service manual, and passed all tests.The system met the manufacturer's specifications for the performed service and was returned to use.According to the information provided, the v60 device was in clinical and therapeutic use on a covid-19 positive patient with a poor prognosis and do not intubate (dni) status.During the course of ventilator support, the patient went into respiratory arrest and advanced cardiovascular life support (acls) was performed.The resuscitation attempt was unsuccessful and the patient subsequently expired.In reviewing the provided drpt, a high priority alarm of ¿blower temperature too high¿ with error code 1122 populated on the screen at 9 am on 11/23/21.Then, at 11:05 am on the same day, the device alarmed ¿blower temperature too high¿ and ultimately led the device to go into an inoperative mode.It was also noted that excessive amounts of ¿high rate¿ priority alarms for several hours until the vent was inoperable.The respiratory therapist (rt) was present to witness the occurrence and noted a black display screen with audible and visual alarms.Device investigation by a philips authorized service provider (asp) confirmed the presence of 1122 and 1002 error codes however, they were not able to duplicate the issue.Based on the information provided and internal investigation, the v60 device performed according to manufacturer specifications.The device alarmed ¿blower temperature too high¿ with error code 1122 to notify the clinician that the blower temperature is greater than 95 degrees celsius for over a minute.However, the issue was not resolved and the blower temperature continued to increase greater than 115 degrees celsius for over 10 minutes.As a result, the device became inoperable as a safety mechanism.No causal relationship can be attributed to the patient expiring and alleged device malfunction.The contribution of the device to the patient expiring cannot be ruled out as the clinician failed to rectify the high-temperature blower issue.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 13120325
• MDR Text Key: 282985927
• Report Number: 2031642-2021-05915
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 08/17/2022
• Date Device Manufactured: 03/14/2019
• 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): Death