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

Model Number V60

Device Problem Power Problem (3010)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

The customer reported the ventilator shut down mid-use while connected to ac power.When the customer examined the ventilator, the battery was "flat"; however, it accepted a charge.The ventilator shut down mid-use.No harm was reported.No additional details were provided.

Manufacturer Narrative

Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone #: (b)(6).Reporter phone # (b)(6).

Manufacturer Narrative

When the ventilator shut down mid-use, the ventilator was removed from the patient.No harm was reported.No additional details are available.The customer detailed that the ventilator had been running on (b)(6) 2021, on ac power at a high rate; this continued until late on (b)(6) 2021, with 100% oxygen interventions recorded.At this time, the log recorded that the ventilator then went onto battery power and ran for just short of 3 hours before shutting down early on (b)(6) 2021.The log then records a series of on/off events with the ventilator not connected to a patient.This matches the description of events that the customer's team leader obtained, that the ventilator was removed from the patient, and the staff tried to get the ventilator working, but it kept shutting down.Alarms observed by staff were unknown but observed to be functional in workshop tests.Alert messages are seen by staff unknown; all expected messages are seen in workshop tests.When the ventilator was received in the customer's biomedical workshop, the battery was low, and the alerts produced high urgency alarms.As the machine was set up, it was left with the amber alarm for the low battery, visual and sonic.The customer performed a test of ventilator function and checked the power inlet.No-fault observed.The root cause was determined that the ventilator was not connected to ac power, and the ventilator powered down when the backup battery became depleted.There was no device malfunction detected.

• 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: 13113511
• MDR Text Key: 287929463
• Report Number: 2031642-2021-05910
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/29/2021
• Supplement Dates FDA Received: 01/21/2022
• Date Device Manufactured: 08/24/2012
• 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