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

Model Number V60

Device Problems Noise, Audible (3273); Excessive Heating (4030)

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

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting institution phone number: (b)(6).

Event Description

The customer reported overheating and abnormal noise problem.The customer reported that the unit was not in use on patient.No reports of impact to the patient.The customer contacted product support and the users reported that the device has an overheating issue and an anomalous noise.There are no error messages.There are no reports of impact on the patient.The customer requested a check by a technician.As the device was in the covid department, the fan was sanitized.The device is pending customer approval for repair.

Manufacturer Narrative

The field service engineer (fse) replaced the blower and ran functional tests with a positive outcome.The ventilator is ready for clinical use.

Manufacturer Narrative

The blower assembly was returned for failure investigation.The blower assembly failed testing.Bad temperature sensor lm20 generated the blower temperature high error code.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14136191
• MDR Text Key: 289448702
• Report Number: 2031642-2022-01008
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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: 1053614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 04/22/2022; 07/25/2022
• Supplement Dates FDA Received: 05/13/2022; 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• 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