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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/27/2021

Event Type  malfunction  

Event Description

The customer reported experiencing issues and needs parts.The device was not in clinical use.No patient or user harm was reported.

Manufacturer Narrative

G4: (b)(6) 2021.G5: 510k: k102985.B4: (b)(6) 2021.The field service engineer (fse) advised replacement for the dim liquid crystal display (lcd) and central processing unit (cpu) tray cover.

Manufacturer Narrative

G5: 510(k)#: k102985.B4: (b)(6) 2021.The customer confirmed they were experiencing a user interface failure and they needed to replace the central processing unit (cpu)tray cover that was broken.The customer replaced the user interface assembly to resolve the user interface failure; the (cpu) tray was replaced to resolve the issue with the (cpu) tray cover.Although requested to be returned, the removed component was not received for evaluation at this time; therefore, the root cause at the component level could not be determined.An evaluation will be performed if the removed component is received, and an additional report will be submitted.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11894714
• MDR Text Key: 252960653
• Report Number: 2031642-2021-03855
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/27/2021
• Date Manufacturer Received: 07/25/2021
• 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