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

Model Number V60

Device Problems Improper Flow or Infusion (2954); Noise, Audible (3273)

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

Event Date 06/17/2022

Event Type  malfunction  

Event Description

The biomed reported that the device has a low o2 issue and needs a fan fixed and feet on device replaced.It was unknown how the issue was found.No patient or user harm reported.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

The biomed reported that the issue was found during preventative maintenance.There were no errors generated and no alarms were observed.It was then reported that the device had low oxygen values.There was no patient involvement when the issue occurred.No patient or user harm reported.

Manufacturer Narrative

H10: field service engineer (fse) ordered parts, however they indicated the required parts are on back order.Follow up for final repair and disposition information has been sent but not yet replied to.Multiple good faith efforts were made to retrieve device evaluation, repair, and operational status on 06/23/2022, 17/22/2022, 08/23/2022, and 01/18/2023, however, yielded no response from the customer.It is unknown if any parts or repairs have been conducted.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14858106
• MDR Text Key: 301257223
• Report Number: 2031642-2022-01751
• Device Sequence Number: 1
• Product Code: MNT
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Yes
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 06/27/2022; 01/18/2023
• Supplement Dates FDA Received: 07/22/2022; 01/31/2023
• Date Device Manufactured: 01/11/2010
• 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