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

Model Number V60

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/28/2023

Event Type  malfunction  

Event Description

The staff prepared to use the ventilator for the patient.In the process of pushing the ventilator to the ward, the ventilator cart suddenly fell apart, and the main engine of the ventilator fell on the staff's feet.Investigation is ongoing.

Manufacturer Narrative

H10: philips international key market reports the v60 unit itself was identified to be in good condition and no repair needed.Additionally, it was reported that the trolley was replaced by the hospital.Investigation remains ongoing.

Manufacturer Narrative

H10- additional details regarding the injury, it was reported that after the device was used on a patient, the nurse was pushing back the unit to the nursing station, and the wheels of the car suddenly fell off.When the nurse went to pick up the machine; the device fell and hit the nurse's foot.The injury was noted as minor contusion, and ointment was applied.This concludes the investigation.

• 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: 16910561
• MDR Text Key: 314985614
• Report Number: 2518422-2023-10921
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/22/2023; 06/13/2023
• Supplement Dates FDA Received: 06/09/2023; 06/15/2023
• Date Device Manufactured: 04/02/2021
• 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