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

Model Number V60

Device Problem Break (1069)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

The customer reported that the display was damaged.There was no patient involvement when the issue occurred.No patient or user harm reported.Per the diagnostics performed by the engineer, the customer stated that the device had a damaged display by unknown causes.The customer requested the part numbers to replace the damaged parts.The remote service engineer (rse) provided the part numbers for the rear bezel, cable, switch pcba, and touchscreen (front bezel).Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

The customer reported that the pcba to uipcb cable was replaced, and the touchscreen was also replaced.It was then reported that the back case has not been replaced due to the part being on back order.The necessary repair will be completed once part is received.

Manufacturer Narrative

The backordered back bezel was replaced.A field service engineer (fse) was dispatched to the customer site.The touchscreen and rear bezel were broken previously during a service repair.The fse replaced the rear bezel.A performance verification test was completed.The returned device was ready for patient use.

• 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: 15213669
• MDR Text Key: 303073040
• Report Number: 2031642-2022-02107
• 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

• 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
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 07/29/2022; 10/05/2022
• Supplement Dates FDA Received: 08/26/2022; 11/01/2022
• Date Device Manufactured: 07/07/2015
• 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