MAUDE Adverse Event Report: MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number PWD50+SFHORXOK3

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Injury (2348)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

A maquet field service technician evaluated the power led light and did not find any failures.The surgical light system was functioning according to specifications.Maquet determined that the assembly that failed belongs to a non-maquet device that was combined to the powerled light.Maquet determined that the assembly that failed belongs to a (b)(6) device that was combined to the powerled light : model portegra ot25bo5 sn: (b)(4) and its spring arm ot50u010-mq sn:(b)(4).Maquet sas forwarded the complaint to (b)(4).

Event Description

The customer reported that a x-ray protection shield and its spring arm detached and fell off of the ceiling suspension while doctor adjusted it during a surgical intervention.It was reported that the doctor's hand was injured.There were no injuries to patient.This event is being reported per 21cfr part 803 because the maquet device contributed to the reported event, as it was combined to the foreign device that failed.Factory reference number: (b)(4).

Manufacturer Narrative

(b)(4).Maquet was not able to evaluate the assembly that failed as it was discarded by the customer.Maquet determined that the most likely cause of the reported event is a c-clip - located at the junction between the light and the x-ray protection system - that was incorrectly set by the user facility.The power led series installation manual includes instructions related to the positioning of the c-clip.Additionally, the device was directly involved with the reported incident and was being used for treatment of patient when the event occurred.

Event Description

(b)(4).

Event Description

(b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): FREDERIC LELEU - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 5726131
• MDR Text Key: 47434501
• Report Number: 9710055-2016-00040
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: PWD50+SFHORXOK3
• Device Catalogue Number: PWD209014.C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/28/2016; 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2011
• 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
• Patient Outcome(s): Other