MAUDE Adverse Event Report: HOLGER ULLRICH ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113302B3

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

Patient Problems Pain (1994); Injury (2348)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

At 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

It was reported that a case of compartment syndrome occurred.The patient was treated on an alphamaxx table.Further information concerning patient data, performed surgery, used product(s) and malfunction were asked, but not yet provided when this report was created.Manufacturer reference: (b)(4).

Manufacturer Narrative

The customer reported that a compartment syndrome occurred during surgery with a getinge-maquet product.A getinge-maquet field service engingeer has visited the clinic and investigated the products in question.He confirmed that no damage or malfunction could be found on the or table or attached accessories.Furhter information concerning patient data (age, weight, height, preexisting medical conditions), performed surgery and patient outcome was requested from the hospital.The hospital refused to provide this information due to protection of personal information.A compartment syndrome can be caused due to different influences ( patient position, operating time, lithotomy position, ankle above heart level, strong lower leg and / or high bmi, intraoperative compression of the large vessels, a history of cardiovascular issues).Since no product malfunction was found, we assume that in this case several unfavorable factors came together and thus led to the described injury.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer reference: (b)(4).

• Brand Name: ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 8582297
• MDR Text Key: 144138987
• Report Number: 8010652-2019-00015
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 113302B3
• Device Catalogue Number: 113302B3
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other