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

Model Number V60

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Respiratory Distress (2045)

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.Patient information not yet provided.

Event Description

A customer reported that the inspiratory positive airway pressure (ipap) rose from 10 to 30.This patient was admitted through the emergency room for acute respiratory distress syndrome (ards) and placed on a v60 ventilator.The ipap increased from the setting of 10 to 30 and the patient's sao2 decreased from 95-80%.The patient's tube was replaced and another v60 was placed on the patient and the patient recovered.The patient had been on fio2 100% prior to the event.

Manufacturer Narrative

Device evaluation: a field service engineer performed a run in test was performed at a service center and the reported phenomenon was not duplicated.No error which indicated the abnormality of the unit was not recorded in the event log and only the normal alarm was recorded.The value of pressure and that of airflow were measured for the unit check then no abnormality was found.The phenomenon was not duplicated or no abnormality for the unit was found so the external influence such as a circuit is assumed to generate this complaint.The unit was checked overall and run in tests and functionally tested.The software version was checked to 2.30.A previous maintenance was performed within 3 months and no parts which is required to be replaced.The device was brought to a service center.No root cause could be determined as no faults were found and no parts were replaced.The ventilator log was reviewed and there was no evidence of any hardware issues.There was off-label use of accessories listed in concomitant medical products.These accessories are not on the approved list in the v60 user manual and can affect ventilator performance.

• 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: robert corning ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7240059
• MDR Text Key: 98963361
• Report Number: 2031642-2018-00210
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2014
• 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