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

Model Number V60

Device Problems Blower (738); Infusion or Flow Problem (2964); No Pressure (2994)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019. Date of report: 05dec2019.

Event Description

The customer reported pressure occlusion and a stalled blower. There was patient involvement, but no one was harmed. The manufacturer¿s field service engineer (fse) confirmed the reported issue. The fse checked the patient circuit, performed performance testing and checked the blower and software. The fse determined that the blower could not produce sufficient pressure or the blower speed signal had failed. The fse verified that the blower was connected to the mc pcba (motor controller printed circuit board assembly), verified that the blower rpm (revolutions per minute) monitor increased above 3000 rpm when the pressure controller was set to a value above 0 (cmh20) centimeters of water. The fse advised if the blower rpm did not increase above 3000 rpm to replace one of the following to re-establish the tachometer signal. The fse advised may be the blower, mc pcba, and/or (central processing unit). In reference to the patient circuit occlusion error, the fse checked the patient circuit for bulk liquid, crimps, or blocked filter. The fse confirmed the ventilator and alarm settings were appropriate. The fse advised if the problem persisted to provide alternative ventilation and to service the ventilator. The fse replaced the blower assembly and provided proper operation check. After corrective maintenance, the equipment is operational and complies with the manufacturer's specifications. The necessary checks have been carried out to certify the return to the pre-failure operating conditions.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 9418498
• MDR Text Key: 179134666
• Report Number: 2031642-2019-10755
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (Y/N): N
• Reporter Country Code: SP
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/05/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• 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
• Event Location: No Information
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/03/2010
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse