MAUDE Adverse Event Report: DATEX-OHMEDA, INC. ENGSTROM; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problem Failure to Power Up (1476)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that there was a malfunction resulting in a failure to power up that could cause loss of mechanical ventilation during a case.There was no patient injury.

Manufacturer Narrative

The distributor performed a checkout of the equipment and confirmed the reported complaint.The display board cable was replaced to resolve the issue.Block a: patient information could not be obtained due to country privacy laws.Block h4: date of device manufacture year is 2007.The month of manufacture was unavailable at time of mdr filing.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

• Brand Name: ENGSTROM
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 19141555
• MDR Text Key: 340693798
• Report Number: 2112667-2024-02096
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K140575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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