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

Model Number PWD75SFHDRK3

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problems Laceration(s) (1946); No Patient Involvement (2645)

Event Date 08/28/2016

Event Type  Injury  

Manufacturer Narrative

A maquet field service technician (fst) evaluated the device and found that the metal dust cover of the light system was dislodged.Maquet assumes that the device failed to meet its specification due to an incorrect attachment of the dust cover or a detachment due to repeated collisions.Additionally, it device was directly involved with the event, however was not being used for treatment or diagnosis of the patient when the event occurred.The fst repaired the device and returned it to service.The power led series installation program includes a verification of all covers of the device.

Event Description

The customer reported that a metal dust cover of the light system was dislodged and a nurse was cut when she touched it.The cut required stitches.(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: 5980010
• MDR Text Key: 55717428
• Report Number: 9710055-2016-00084
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2016,08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PWD75SFHDRK3
• Device Catalogue Number: 568436010.C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2016
• Distributor Facility Aware Date: 08/30/2016
• Device Age: YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2016
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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