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

Model Number V60

Device Problems Defective Alarm (1014); Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problems Hypoxia (1918); Respiratory Distress (2045)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 08dec2020.

Event Description

The biomed reached out to philips remote service engineer (rse) to report back up alarm failed.The biomed advised error code consistent with backup alarm failed was in the significant event logs.The rse advised suspect central processing unit (cpu) printed circuit board assembly (pcba) as per service manual and rse provided part identification.No diagnostic report (drpt) was provided for review.This was a malfunction of the cpu pcba.The biomed advised the issue is resolved after replacing the cpu pcba.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed ventilation therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, the patient was receiving therapy via the v60 device, the device generated a backup alarm failed error code, and the patient experienced an event of respiratory distress and hypoxia; peripheral capillary oxygen saturation values not reported.Hospital staff then removed the patient from the v60 device, administered low flow oxygen via nasal cannula; liters per minute not reported, and was then placed on another ventilator; brand and model not reported.No relevant laboratory data was reported.The patient experienced mild harm with no details reported.The outcome of the patient experiencing mild harm is unknown.

Manufacturer Narrative

G4: 09dec2020.B4: 09dec2020.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

The cpu pcba was returned for failure investigation.No anomalies were noted during visual inspection.Upon further testing, the customer complaint was verified.Root cause is failure of annunciator ls1 due to contamination inside the component.

• 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: 10972693
• MDR Text Key: 220422877
• Report Number: 2031642-2020-04444
• 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,Followup
• Report Date: 03/22/2022

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 Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 11/12/2020; 10/14/2021
• Supplement Dates FDA Received: 12/09/2020; 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER