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

Model Number V60

Device Problems Volume Accuracy Problem (1675); Gas/Air Leak (2946)

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

Event Date 09/24/2021

Event Type  malfunction  

Event Description

The customer reported that while providing therapy, a ventilator was having tidal volume issues.The device was then evaluated in a biomed shop where a high priority low leak co2 alarm was confirmed.The device was in clinical use at the time the issue was discovered.The patient was removed from the ventilator without incident.There was no patient or user harm reported.The device was evaluated by the customer and a philips remote service engineer (rse).The customer confirmed and duplicated the reported issue.The customer reported that they had ordered a flow sensor and were waiting on its arrival to repair the device.Multiple attempts were made to retrieve additional device repair or diagnostic information, however, yielded no response from the customer.When this information becomes available, a follow up report will be submitted.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 12669183
• MDR Text Key: 277697995
• Report Number: 2031642-2021-05341
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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
• Date Manufacturer Received: 09/24/2021
• Date Device Manufactured: 04/28/2011
• 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