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

Model Number V60

Device Problem Intermittent Loss of Power (4016)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

The customer reported that the unit has no power.The customer reported that the unit was not in use on a patient.The customer contacted product support and the multi-vendor (mv) has a v60 and there is no power.The unit does not power on in ac or battery power.Product support recommended the power supply and possibly the internal battery.The battery is only 1.5 years old and might have been damaged since it was depleted.The (mv) will order the power supply and get unit to power on, then check to see if the battery will charge.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

Per biomedical engineer the power supply was replaced to address the reported issue.The biomed reported that the battery charged after being left for 24 hours plugged in ac power.The unit is now back in service.

Manufacturer Narrative

The power supply was returned for failure analysis.The customer complaint was verified.The root cause is failure of power supply assembly.Q9 shorted.

• 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 ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14957491
• MDR Text Key: 302779026
• Report Number: 2031642-2022-01842
• 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: 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: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/08/2022; 11/22/2022
• Supplement Dates FDA Received: 08/02/2022; 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• 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