MAUDE Adverse Event Report: HAUNAUPORT ALPHAMAX DUO; TUBING, PRESSURE AND ACCESSORIES

Model Number UNKNOWN

Device Problem Unintended Movement (3026)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 23rd march, 2021 getinge became aware of an issue with one of surgical lights.As it was stated, the light head drifted downwards towards the patient's head.There was no injury reported however we decided to report the issue in abundance of caution as contact of the light head with the patient or sterile field may lead to the contamination.

Event Description

On 23rd march, 2021 getinge became aware of an issue with one of our devices - haunauport alphamax duo.As it was stated, the device drifted downwards towards the patient's head.There was no injury reported however we decided to report the issue in abundance of caution as contact of the light head with the patient or sterile field may lead to the contamination.Manufacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of fields deems required.This is based on additional details obtained from service unit.B5 describe event or problem previous: on 23rd march, 2021 getinge became aware of an issue with one of surgical lights.As it was stated, the light head drifted downwards towards the patient's head.There was no injury reported however we decided to report the issue in abundance of caution as contact of the light head with the patient or sterile field may lead to the contamination.Corrected: on 23rd march, 2021 getinge became aware of an issue with one of our devices - haunauport alphamax duo.As it was stated, the device drifted downwards towards the patient's head.There was no injury reported however we decided to report the issue in abundance of caution as contact of the light head with the patient or sterile field may lead to the contamination.D4 serial # previous: (b)(6).Corrected: (b)(6).D1 brand name previous: surgical light.Corrected: haunauport alphamax duo.D2b procode previous: fsy.Corrected: byx.

Manufacturer Narrative

Getinge became aware of an issue with one of our devices - hanauport alphamax duo.As it was stated, the device drifted downwards towards the patient's head.There was no injury reported however we decided to report the issue in abundance of caution as contact of the light head with the patient or sterile field may lead to the contamination.It was established that when the event occurred, the surgical light did not meet its specification as it should not move unexpectedly, and it contributed to event.Upon the event occurrence the device was being used for patient treatment.The pneumatic brake failure was caused by a leakage due to a tear of the tube at the crimping point.The breakage of the tube at the crimp can be due to : a pressure higher than the working pressure (> 5 bars).A pull on the tube by rotation when the arm is locked.A weakening of the mechanical properties of the tube during the pipe machining or during the crimping operation.The brakes are tested by the supplier reiff at 8 bars during 48 hours.The pressure in use must not exceed 5 bars max.A destructive test is also carried out to ensure that the ferrule is properly attached to the pipe.A weight of 15 kg is applied for more than 24 hours.An underwater leakage test is also carried out.To prevent any safety issue the failure of the braking system is detectable, during positioning, before surgery because this system is a permanently air-fed brake.The procedure to use the air brakes is described in the user manual 083112301 ed1b page 25.The product range hanauport alphamax is no longer supported, both references, ard314403555 & hm56078936, are no longer distributed.We believe that overall the devices on the market are performing correctly.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• Brand Name: HAUNAUPORT ALPHAMAX DUO
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• MDR Report Key: 11575035
• MDR Text Key: 242430987
• Report Number: 9710055-2021-00114
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1