MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG TRULIGHT 5000 / 3000 CEILING DUO; SURGICAL LIGHT

Model Number 4038210

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hematoma (1884)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Customer reported that the trulight 5000 light head fell into the user¿s arms during cleaning, causing hematomas to the arms of the user.The user was noted to be hypertensive prior to the event, but there was no report of further elevation of blood pressure.The hematomas were treated with an anti-inflammatory gel.It was reported that there were no clinical consequences or hospitalization associated with this complaint.The severity of this injury was determined as non-serious.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

The hospital technician reassembled the head light, put the retaining segment back on and put a screw on the protective ring.Further investigation is ongoing and results will be provided by a final report.

Manufacturer Narrative

Further investigation determined that the screw which holds the retaining sleeve in place was missing.This allowed the retaining sleeve to move from its position, maybe during the cleaning of this part.If the retaining sleeve is moved from its position the retaining segment is able to move out of the connection between the spring arm and the light head bracket.This allows the light head to detach and fell off.The missing screw was traced to an installation failure of the customer during a previous repair of the light system.The hospital technician reassembled the head light, put the retaining segment back on and put a screw on the retaining sleeve.Based on this, no further actions are necessary.

Event Description

Customer reported that the trulight 5000 light head fell into the user¿s arms during cleaning, causing hematomas to the arms of the user.The user was noted to be hypertensive prior to the event, but there was no report of further elevation of blood pressure.The hematomas were treated with an anti-inflammatory gel.It was reported that there were no clinical consequences or hospitalization associated with this complaint.The severity of this injury was determined as non-serious.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TRULIGHT 5000 / 3000 CEILING DUO
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl-zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 16910748
• MDR Text Key: 314990473
• Report Number: 3007143268-2023-00015
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

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 Model Number: 4038210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1