MAUDE Adverse Event Report: VYAIRE MEDICAL REVEL, ENGLISH SERVICE REPAIR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number REVEL, ENGLISH SERVICE REPAIR

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4) h3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire that the device had configuration reset and multiple sch svc alarms.Furthermore, the hours on the device were reset.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.

• Brand Name: REVEL, ENGLISH SERVICE REPAIR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18983466
• MDR Text Key: 338749814
• Report Number: 2021710-2024-18926
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REVEL, ENGLISH SERVICE REPAIR
• Device Catalogue Number: 19260-001-99
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1