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

Model Number 1506-8600-000

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Serial numbers: (b)(4).For 2 of the 2 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.To resolve the 2 events, the ventilator housing was replaced to resolve the reported issue.

Event Description

This report summarizes 2 malfunction events.A review of the events indicated that model 1506-8600-000 ventilator, continuous, facility use a break of a component.1 event was reported for the hooked portion on the bottom of the chassis was broken preventing latching to the base, and 1 event was reported for a damaged ventilator housing preventing it from being latched to the base.These reports were received from various sources.Of the 2 events, 2 did not involve patients.

• Brand Name: CARESCAPE R860
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8536504
• MDR Text Key: 142794380
• Report Number: 2112667-2019-00172
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00840682102346
• UDI-Public: 010084068210234621
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1506-8600-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1