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

Model Number V60

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 08sep2020.

Event Description

The customer reported oxygen (o2) not available and high o2 inlet pressure.The customer went to diagnostics and found that the o2 inlet pressure was 104 pounds per square inch (psi).The remote manufacturer's service technician advised the customer to bleed the o2 trapped between the o2 inlet and the o2 manifold.The customer dropped to 55 on wall and if tanks are connected rises to 57 psi.The customer verified no 10xx or 11xx codes.The remote manufacturer's service technician advised the customer that if the o2 rises over 92 psi that it will end o2 operation and the o2 will be trapped between the inlet and the manifold.The remote manufacturer's service technician advised the customer to perform performance verification test (pvt) and run the unit on tanks and wall o2 to see if the issue can be duplicated.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.

Manufacturer Narrative

H10.Multiple attempts to retrieve device  repair, and operational status has yielded no response from the customer. the complaint will be processed for closure.If additional information becomes available at a later date, the complaint will be reopened, and a supplemental report will be submitted.H11: b3: date of event.G1: contact information updated.H6: codes.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 10505163
• MDR Text Key: 207140303
• Report Number: 2031642-2020-03161
• 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
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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