MAUDE Adverse Event Report: MAQUET GMBH SEAT PLATE EXTENSION, IPC, EU, WASHABLE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 116055DC

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Ulcer (2274)

Event Date 01/31/2024

Event Type  Injury  

Event Description

On 31st january 2024 getinge became aware of an issue with one of our accessories ¿ 116055dc - seat plate extension, ipc, eu, washable used with 720001b2 - meera eu with auto drive.As it was stated and confirmed with the photographic evidence, positioning of the patient over the edge resulted in pressure ulcer with blister formation.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.Ref- (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6) h3 other text : device not returned to the manufacturer.

• Brand Name: SEAT PLATE EXTENSION, IPC, EU, WASHABLE
• 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: 18649859
• MDR Text Key: 334637098
• Report Number: 3013876692-2024-00010
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 116055DC
• Device Catalogue Number: 116055DC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2024
• Distributor Facility Aware Date: 01/31/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2024
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 720001B2 - MEERA EU WITH AUTO DRIVE
• Patient Outcome(s): Other