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

Model Number V60

Device Problems Overheating of Device (1437); Unexpected Shutdown (4019)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

The customer called technical support (ts) and reported that the device is overheating and shuts down.The customer reported there was no patient involvement at the time the issue was discovered.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The rse went through event log with customer.Found the following error messages: 1117 3.3 v supply failed; 111d (cbit) mc pcba adc failed; 1122 (cbit) blower temperature high; 1002 (cbit) blower temperature too high.The rse recommended replacement parts: pm board; mc board; and blower assembly.The customer is requesting onsite support.The rse dispatched for onsite support.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

The repair for this unit cannot be conducted at this time due to the part(s) being on back order.The material has already been requested and an order for the part(s) was placed to conduct the repair of this unit.The material ordered motor controller (mc) printed circuit board assembly (pcba), power management (pm) pcba, aligns with the recommended repair of the reported malfunction per the service manual.When the parts become available the repairs will be conducted.If new information is received and suggest that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

Manufacturer Narrative

H10 a field service engineer replaced the power management pcba (printed circuit board assembly) per v60 service manual to resolve the reported issue.The device passed the required performance verification tests per philips standards and was returned to service.H11 updated contact information and contact office entity.

• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 15329986
• MDR Text Key: 301127815
• Report Number: 2031642-2022-02268
• 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: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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
• Date Manufacturer Received: 01/05/2023
• Date Device Manufactured: 09/17/2010
• 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