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

Model Number V60 V60PLUS VENTILATOR

Device Problems Failure to Run on Battery (1466); Battery Problem (2885)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

E1: reporter phone #: (b)(6).

Event Description

Philips received a complaint on the v60 ventilator, indicating that there was a main battery failure alarm.The device was reported to be in use at the time of the reported problem.No patient or user harm reported.The customer informed the authorized service provider (asp) that the device was in use on a patient who required non-invasive ventilation due to respiratory failure.On (b)(6) 2023 during the nurse's ward round, it was found that the device had an alarm for main battery failure, causing the equipment to stop running and being unable to use which resulted in difficulty breathing for the patient.After the alarm was found, the nurse immediately used another device to maintain breathing for the patient and then replaced the ventilator with another non-invasive ventilator to continue treatment.After the patients breathing stabilized, the v60 ventilator which experience the battery alarm was taken out of use for repair.This investigation is ongoing.

Manufacturer Narrative

H10: in a good faith effort (gfe) response from the authorized service provider (asp) received on 07jan2024, it was stated that the patient did not desaturate or experience any harm other than the difficulty in breathing following the device issue.The asp stated that the customer had onsite service performed by a third party.The third-party vendor replaced the battery, and the device was confirmed as fully operational and returned to use.The device diagnostic report (drpt) was not available to be provided by the asp.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18409328
• MDR Text Key: 331505998
• Report Number: 2518422-2023-38314
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)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,Health Professional,User Facility
• Reporter Occupation: Physician
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/07/2024
• Supplement Dates FDA Received: 01/08/2024
• Date Device Manufactured: 09/30/2014
• 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