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

Model Number V60

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Based upon the information provided, it is unknown if the unit was in use on a patient at the time of the reported event, however, no patient harm or injury were reported.

Event Description

It was reported to philips by a customer that the unit had a primary alarm failure and power board is faulty.Based upon the information provided, it is unknown if the unit was in use on a patient at the time of the reported event, however, no patient harm or injury were reported.The device was evaluated remotely by a philips remote service engineer (rse).Upon further inspection and review of the device and diagnostic report, the customer stated the unit had an active primary alarm failure, and there was no ac power.The unit only operated on battery and the 24 volts was on service mode displaying 1 volt.The customer verified the 120 ac volts went into the power supply, but no 24 dc volts went into the power management pcba with volt meter.The unit had software (b)(4) and the speaker was causing the primary alarm failure.The customer also verified code 1002 was in the significate log.The customer and rse verified (b)(4) was never implemented on this unit.The rse recommended power supply and speaker part for repair.The customer emailed back and stated the speaker issue was caused by the speaker connecter that was not fully secure in the power management pcba.The customer reseated the connector and the speaker issue was solved.He is still waiting for the power supply.The customer reseated the connector and the speaker issue was solved.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other anomaly was reported.

Manufacturer Narrative

The customer stated that the power supply and power management pcba were replaced to resolved the issue.

• 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: 12471773
• MDR Text Key: 271452669
• Report Number: 2031642-2021-04935
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/26/2022
• Date Device Manufactured: 03/10/2011
• 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