MAUDE Adverse Event Report: DATEX-OHMEDA, INC AESTIVA 7900; ANESTHESIA GAS MACHINE

Device Problems Component Falling (1105); Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)

Patient Problems Head Injury (1879); No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

The hospital reported that, as the patient stretcher was being repositioned during an endoscopy case, the nibp hose, attached to the pdm module and b650 monitor, became taut.The movement of the stretcher caused forward pressure to be applied to the monitor.The monitor reportedly fell forward, striking the head of the nurse.The monitor came to rest on the forward stops of the mount at a position of approximately 30 degrees above horizontal (original position was approximately 90 degrees).

Manufacturer Narrative

Pt gender: female.Based on pictures, description, parts provided and engineering analysis performed, the pinch bolt had stripped threads on the bearing block and prevented the ability to add additional friction to the bearing required to support the monitor load.Without the additional friction, the additional force from the movement of the tethered patient caused the monitor to pivot forward until it came to rest on the stops.The amount of energy of the monitor pivoting forward is 7.6 joules.The cause of the stripped threads is undetermined.

Manufacturer Narrative

The customer had reported the nurse involved in the event did not seek medical attention and received only first aid at the time of the event.In addition, it was reported the nurse did not take time off from work.Follow-up mdr submitted 10/26/2015 should have been updated to indicate: product problem.Malfunction.Fields to complete patient and device codes were not available on the initial mdr filed.Codes for patient and device codes have been included in this follow-up mdr.

• Brand Name: AESTIVA 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 5032702
• MDR Text Key: 24149336
• Report Number: 2112667-2015-00121
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K023366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Followup,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/26/2015; 04/08/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other