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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/19/2021

Event Type  malfunction  

Event Description

The customer reported the unit fails the electrical safety test on the oxygen retention plate.The device was not in clinical use.There was no patient/user harm was reported.The customer confirmed the reported failure.The customer spoke to technical support.The lock tight on the screws was causing the electrical safety test to fail.The customer cleaned off the lock tight on the screws, and that fixed the issue.The unit is working just fine and passed preventive maintenance (pm) tests.

• Brand Name: V60
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 11531344
• MDR Text Key: 243172795
• Report Number: 2031642-2021-03069
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial

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: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/19/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/19/2021
• 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