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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Run on Battery (1466)

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

Event Date 04/23/2024

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).

Event Description

Philips received a complaint from the customer, reporting a battery failure alarm occurred on the v60 ventilator.The device was not in clinical use.There was no report of harm.There was no patient or user impact.The device did not meet specification for intended use and was removed from service.A philips remote service engineer (rse) evaluated the issue with the biomedical engineer (bme) and reported the device functioned well with the battery removed.The rse advised battery replacement.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19215900
• MDR Text Key: 341421433
• Report Number: 2518422-2024-23978
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

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: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/30/2024
• Date Device Manufactured: 04/06/2021
• 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