MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESCAPE R860; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problem Fire (1245)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

It was reported that there was an odor and small amount of smoke in the respiratory icu.The ventilator in patient use was found to have a burned capacitor of the air pump.There was no patient injury.

Manufacturer Narrative

Ge healthcare âs investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a: patient information could not be obtained due to country privacy laws.Block e1: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Block d4 unique identifier:(b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718 h3 other text : device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The end user confirmed it was the capacitors from the air compressor that generated smell and smoke.After engineer replaced the non-ge capacitor, there was no further issue with the device.H3 other text : the end user confirmed it was the capacitors from the air compressor that generated smell and smoke.After engineer replaced the non-ge capacitor, there was no further issue with the device.

• Brand Name: CARESCAPE R860
• 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: 18093439
• MDR Text Key: 327648781
• Report Number: 2112667-2023-05864
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K210384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Date Device Manufactured: 11/09/2020
• 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