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

Model Number V60

Device Problems Occlusion Within Device (1423); Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The caller reported occlusion and the blower was not running.The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.

Manufacturer Narrative

B4: (b)(6) 2018.D4: (b)(4) updated udi.E3: biomedical engineer.G1: updated contact name.G4: 20jun2018.This is follow-up #1.Technical support suggested for customer to replace the blower.Customer was able to resolve issue.The reported problem was not confirmed.The unit was repaired and in working condition for patient use.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

H10.Technical support suggested for customer to replace the blower to resolve the reported issue of the blower not running.The customer reported that the issue was not confirmed during evaluation.No part was replaced to address the reported problem.The unit passed testing and in working condition for patient use.D4 - udi number added.H11.G1 - updated contact information.

• 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): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: kimberly shelly ; 2271 cosmos court; ste a; carlsbad, CA 92011 ; 7247330200
• MDR Report Key: 7547205
• MDR Text Key: 109457630
• Report Number: 2031642-2018-01095
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: 08/23/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/27/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2011
• 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