MAUDE Adverse Event Report: HOLGER ULLRICH MAQUET UNIVERSAL FRAME; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 100724A0

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pressure Sores (2326)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer reported pressure ulcers caused during surgery with getinge - maquet product.Pressure ulcers can be caused due to different influences (patient age, condition of the skin, duration of the operation, unfavorable positioning of the patient, etc.).It was reported by the customer that this is the only case in the clinic.After this case a getinge - maquet representative visited the customer and joined a procedure.No complication reported and no pressure ulcers were visible after the case.Therefore we assume that in this case several unfavorable factors came together and thus led to the described injury.Since an injury was reported to getinge - maquet we decided to report this case to the competent authorities.Getinge - maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Customer reported pressure ulcers caused during surgery with getinge - maquet product.(b)(4).

Event Description

(b)(4).

• Brand Name: MAQUET UNIVERSAL FRAME
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 7337855
• MDR Text Key: 102348240
• Report Number: 8010652-2018-00006
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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: 100724A0
• Device Catalogue Number: 100724A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 02/15/2018
• Supplement Dates FDA Received: 03/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other