MAUDE Adverse Event Report: DATEX-OHMEDA, INC. ENGSTROM; CRITICAL CARE VENTILATER

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The caster was ordered for replacement to resolve the issue.

Event Description

The hospital reported that the caster came off the base which could cause the unit to tip or fall.There was no report of patient involvement.

• Brand Name: ENGSTROM
• Type of Device: CRITICAL CARE VENTILATER
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski
• MDR Report Key: 11290237
• MDR Text Key: 232427040
• Report Number: 2112667-2021-00339
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2021
• 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
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2013
• 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