MAUDE Adverse Event Report: MAQUET GMBH EXTENSION DEVICE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 141901B0

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Abrasion (1689)

Event Date 09/19/2023

Event Type  Injury  

Event Description

On 19th september 2023 getinge became aware of an issue with one of our devices ¿ 141901b0 - extension device used with 100375a0 - extension shoe and 100376a0 - inlay pad including bar, disposable.As it was stated, the patient's foot was injured (abrasion and damage to the skin) due to incorrect assembly of the handle by the user.The information about medical intervention was not provided by the customer but, according to estimation of our clinical expert, in this kind of injury it is required.Therefore, we decided to report the issue due to serious injury of the patient.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.

Manufacturer Narrative

Getinge became aware of an issue with one of our devices ¿ 141901b0 - extension device used with 100375a0 - extension shoe and 100376a0 - inlay pad including bar, disposable.As it was stated, the patient's foot was injured (abrasion and damage to the skin) due to incorrect assembly of the handle by the user.The information about medical intervention was not provided by the customer but, according to the estimation of our clinical expert, in this kind of injury, it is required.Therefore, we decided to report the issue due to the serious injury of the patient.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment and was directly involved with the reported incident.As no malfunction of the device was confirmed, it has been assessed that the getinge device did not fail to meet its specification.A review of the received customer product complaints revealed that in the past the issues did not lead to serious injury to the user.The issue is a single and isolated case.There was a failure in the assembly of the handle on the customers¿ part.It was disassembled and assembled incorrectly.The affected devices were inspected by the getinge service technician.Based on the photographic evidence provided by the ssu, it could be noticed that the black rubber ring was placed in the wrong configuration with the remaining locking mechanism components, what resulted in the loosened fixture.According to the information provided by the ssu, the accessory¿s assembly has been fixed and the device was used correctly again and experienced no errors or failures.The staff was able to lock the patient¿s foot normally.New training has been suggested for the hospital staff.Based on the conversation with the hospital staff, the accessories have been working normally.The equipment was released for usage.In the instructions for use (ifu 1419.01 en 31, page 21), the user is warned that loose or loosened securing elements may cause injuries.When mounting, and after every adjustment, the user shall tighten all of the locking elements (handle screw, locks, levers, etc.) of the product and check the firm seating of the locking elements.The user is also warned (ifu 1419.01 en 31, page 19) that the products / accessories not attached properly may loosen and cause injuries.The user shall always ensure that all locking elements (offset lever, setting clamps, catches etc.) of the product / accessory are closed and movable parts are fixed properly.Based on the information provided by the ssu it has been evident that the user utilized the device disregarding the safety notes from the instructions for use.In summary and as a result of the performed root cause evaluation, it was concluded that the investigated issue was caused by the user error.The hospital team is aware of this fact, the ssu is already in discussions to carry out new product training with the hospital's team of nurses.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous h3a device evaluated by manufacturer: no; corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other; corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer; corrected h3c if other provide code - explain: n/a.

Event Description

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

• Brand Name: EXTENSION DEVICE
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: kehler strasse 31; rastatt
• MDR Report Key: 17833807
• MDR Text Key: 324468207
• Report Number: 3013876692-2023-00043
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 141901B0
• Device Catalogue Number: 141901B0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2023
• Distributor Facility Aware Date: 09/19/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2023
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 100375A0 EXTENSION SHOE100376A0 INLAY PAD
• Patient Outcome(s): Required Intervention