MAUDE Adverse Event Report: MAQUET GMBH PAIR OF LEG PLATES, 4-PART; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 113373BC

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 12th december 2023 getinge became aware of an issue with one of accessories - 113373bc - pair of leg plates, 4-part.As it was stated, the user cut their index finger when removing the leg plates.According to provided information, the cut was superficial and only the plaster was applied.No stitches were necessary.We decided to report the issue based on the potential for serious injury if the situation, namely the user's body cut during use of the leg plate, was to reoccur.

Manufacturer Narrative

The importer report was generated as a result of a mistake in the decision tree in foreign reporting countries which a colleague at the manufacturer started correcting at the exact time as the mfg emdr initial report was sent and emdr follow up report was generating.As the decision tree was changed from version 1 to version 2, a mistake was made and they chose the option resulting in ¿serious injury¿ which was corrected before the decision tree was confirmed.Unfortunately, as the emdr initial (manufacturer) was sent at the same time, the emdr initial for importer was autogenerated.The injury in the complaint was never considered as serious.It has been confirmed the injury of the user was not serious.Therefore, the importer report is not required.The incident will be further investigated under manufacturer report ref.: 8010652-2023-00147.

Event Description

Ref.(b)(4).

• Brand Name: PAIR OF LEG PLATES, 4-PART
• 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: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 18382869
• MDR Text Key: 331198374
• Report Number: 3013876692-2023-00063
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 113373BC
• Device Catalogue Number: 113373BC
• 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: 02/16/2024
• Distributor Facility Aware Date: 02/16/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2024
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other