MAUDE Adverse Event Report: MAQUET SAS HANAULUX 3004; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD567910910

Device Problem Device Fell (4014)

Patient Problems Head Injury (1879); Swelling (2091)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).

Event Description

On (b)(6) 2019 maquet (b)(4) became aware of an event with one of the surgical light- hanaulux 3004.As it was stated, at the beginning of the surgery light head of the device fell down on patient's head.The surgery was delayed and patient was taken to tomography as he had the swelling on the head.Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074.Exemption # e2018005.(b)(6).On 4th april, 2019 maquet sas became aware of an event with one of the surgical light- hanaulux 3004.As it was stated, at the beginning of the surgery light head of the device fell down on patient's head.The surgery was delayed and patient was taken to tomography as he had the swelling on the head.Fortunately, no other injuries were found.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification.During the event occurrence, the device was being used for patient treatment.During this investigation it was established that the reported issue has resulted in a serious injury or worse.The breakage appeared due to the tearing of the spring arm tube on the edge of the welding joint.The spring arm used in the device is of production year 2005.The spring arm design was adapted by increasing the thickness of the tube from 2006 production onwards.The old version of the tube has 1,35 mm of thickness, whereas the new version of tube has 2,35 mm.As a result, the external diameter of tube has increased to 34 mm.We have addressed this issue with a previous field action msa-2009-003-iu[z-0182/188-2010] and since we see recurrence of the events as we received new complaints from certain markets where these devices are still in use- we started field action msa-2017-002-iu in those markets.Moreover, it is worth to be noted that the sales and service unit opened a capa due to the issue occurrence.It appeared, that even if the product was affected by msa/2017/002/iu field safety corrective action, however the service technician checked the wrong product (volista, not hanaulux) in the hospital in february, 2019.The root cause of this has been identified as a lack of product traceability, communication and informing the employee.To sum the issue up, the root cause of this issue is mixed a design issue existed, but was failed to be correctly addressed due to a sales and service unit error in performing a field action, which in turn led to the event occurrence.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi (b)(4).Contact person: (b)(6).On 4th april, 2019 maquet sas became aware of an event with one of the surgical light- hanaulux 3004.As it was stated, at the beginning of the surgery light head of the device fell down on patient's head.The surgery was delayed and patient was taken to tomography as he had the swelling on the head.Fortunately, no other injuries were found.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification.During the event occurrence, the device was being used for patient treatment.During this investigation it was established that the reported issue has resulted in a serious injury or worse.The breakage appeared due to the tearing of the spring arm tube on the edge of the welding joint.The spring arm used in the device is of production year 2005.The spring arm design was adapted by increasing the thickness of the tube from 2006 production onwards.The old version of the tube has 1,35 mm of thickness, whereas the new version of tube has 2,35 mm.As a result, the external diameter of tube has increased to 34 mm.We have addressed this issue with a previous field action msa-2009-003-iu[z-0182/188-2010] and since we see recurrence of the events - as we received new complaints from certain markets where these devices are still in use- we started field action msa-2017-002-iu in those markets.Moreover, it is worth to be noted that the sales and service unit opened a capa due to the issue occurrence.It appeared, that even if the product was affected by msa/2017/002/iu field safety corrective action, however the service technician checked the wrong product (volista, not hanaulux) in the hospital in february, 2019.The root cause of this has been identified as a lack of training and communication.To sum the issue up, the root cause of this issue is mixed ¿ a design issue existed, but was failed to be correctly addressed due to a sales and service unit error in performing a field action, which in turn led to the event occurrence.

• Brand Name: HANAULUX 3004
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 8488320
• MDR Text Key: 141087027
• Report Number: 9710055-2019-00119
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD567910910
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other