MAUDE Adverse Event Report: MAQUET LEG HOLDER; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 100586B0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.(b)(4).

Event Description

The patient's leg was supported on a leg holder 100586b0 during a surgical procedure.The patient was diagnosed with compartment syndrome after the procedure.(b)(4).

Event Description

Manufacturer reference # (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet gmbh, kehler strasse 31, rastatt, germany 76437.Exemption # e2018004.(b)(4), contact person: (b)(6).The customer reported that a compartment syndrome occurred during surgery with a getinge-maquet product.The clinic confirmed that there was no malfunction of the used product.A compartment syndrome can be caused due to different influences ( patient position, operating time, lithotomy position, ankle above heart level, p strong lower leg and / or high bmi, intraoperative compression of the large vessels, a history of cardiovascular issues).Since no product malfunction was reported, we assume that in this case several unfavorable factors came together and thus led to the described injury.The clinic reported that after one month of hospitalization the patient left the hospital.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAQUET LEG HOLDER
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• MDR Report Key: 8000366
• MDR Text Key: 124876507
• Report Number: 8010652-2018-00025
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100586B0
• Device Catalogue Number: 100586B0
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 98