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

Model Number V60

Device Problems Crack (1135); Human-Device Interface Problem (2949)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported to philips that the screen was cracked by the customer during servicing.There was no patient involvement or harm.This event was reported to have occurred during servicing.The customer stated the screen was slightly out of position which caused the crack when screwing it back together.The philips field service engineer (fse) confirmed the cracked screen.Following the evaluation of the device, the fse replaced the touchscreen to resolve the problem.The unit was then functionally tested and successfully passed specified tests.No other abnormality was observed.

Manufacturer Narrative

The part was returned for failure investigation (fi).The touchscreen was received with cracked or shattered glass.No fi is required, and the returned touchscreen was scrapped.Touchscreen with cracked or shattered glass cannot be tested since the glass has a resistive coating, which if broken, makes the touchscreen nonfunctional.A capa was opened to address issues with touchscreen resistance.Resistances and resistance ratio, which are out of specification, is sufficient to identify the root cause of a touchscreen failure.

• 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: 14114211
• MDR Text Key: 289290839
• Report Number: 2031642-2022-00963
• Device Sequence Number: 1
• Product Code: MNT
• 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,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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2012
• 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