FDA Adverse Event Malfunction Summary report: N

MAQUET, OPERATING TABLE TOP

MDR report key: 1912436 · Received November 2, 2010

Report

Report Number: 8010652-2010-00007
Event Type: Malfunction
Date Received: November 2, 2010
Date of Event: October 13, 2010
Report Date: October 14, 2010
Manufacturer: MAQUET GMBH & CO. KG
Product Code: KXJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE CARBON HEAD REST AND HEAD PLATE ADAPTOR SEPARATED FROM THE CARBON TABLE TOP DURING AN OPERATION. A MAQUET FIELD SERVICE TECHNICIAN (FST) INVESTIGATED THE TABLE AT THE HOSPITAL. THE FST OBSERVED THAT THE ADHESIVE BOND THAT CONNECTS THE ADAPTER TO THE TABLE TOP HAD FAILED. ADDITIONALLY A CONNECTOR SCREW ON ONE SIDE OF THE HEAD REST WAS BROKEN. HOWEVER, THE FST BELIEVES THAT THIS IS CONSEQUENCE OF THE PART FALLING TO THE FLOOR AFTER THE SEPARATION OCCURRED. THE TABLE TOP FULFILLS THE REQUIREMENTS ACCORDING TO (B)(4). ALSO A MECHANICAL STRENGTH TEST WITH SAFETY FACTOR 6 FOR THE HEAD REST INTERFACE HAS BEEN DONE. THE TABLE TOP IS 9 YEARS OLD. POSSIBLY OVERLOAD OR COLLISIONS ARE THE ROOT CAUSE FOR THE BREAK. MAQUET SERVICE HAS ORDERED PARTS TO REPAIR THE TABLE. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

Description of Event or Problem · 1

THE CARBON HEAD REST OF TABLE TOP CAME OFF DURING OPERATION. NO INJURY REPORTED. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAQUET, OPERATING TABLE TOP	TABLE, RADIOLOGIC, CODE KXJ	KXJ	MAQUET GMBH & CO. KG	1150.16B0

Patients

Seq	Age	Sex	Outcome	Treatment
1