MAUDE Adverse Event Report: MAQUET SAS POWERLED II 700; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD569201957

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the small piece of the keypad fell down, but out of surgical field.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation device not returned to manufacturer.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of the surgical lights - powerled ii 700.It was stated a small piece of the keypad fell down, but out of a surgical field.We decided to report the issue in an abundance of caution as any particles falling off during the procedure may fell into the sterile field and cause contamination.According to the information provided by the getinge service technician, the device has been repaired by the replacement of the faulty keypad (ard569201510).It was established that when the event occurred, the surgical light did not meet its specification due to the reported defect, which contributed to the reportable situation.Based on the information collected it was possible to establish that the affected device was not being used for the patient treatment upon the event occurrence.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of complained devices to the install base of powerled ii, we concluded the failure ratio is very low.A root cause analysis was performed by the subject matter expert.It was established that the technician wrote: "the keypad is impacted to the ceiling pendant during remove the ot lamp from the surgical field after a surgical operation, a small piece of keypad is fall down (out of the surgical field), the patient is not affect by this incident." a collision is defined as an impact, other than an impact associated with normal operating circumstances.The probable root cause of the breakage of the keypad is misuse.The ifu (powerled ii ifu 01811 rev.09, pages 67-68) warns the user to move the device carefully to avoid a collision.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: POWERLED II 700
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 15368251
• MDR Text Key: 305163276
• Report Number: 9710055-2022-00361
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD569201957
• Device Catalogue Number: ARD569201957
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1