FDA Adverse Event Malfunction Summary report: N

TRUMPF TITAN OR TABLE

MDR report key: 564429 · Received December 15, 2004

Report

Report Number: MW1034239
Event Type: Malfunction
Date Received: December 15, 2004
Date of Event: November 18, 2004
Report Date: December 6, 2004
Manufacturer: TRUMPF MEDICAL SYSTEMS, INC.
Product Code: FQO
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: TN, US
Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 1

PT WAS POSITIONED ON TITAN BARIATRIC BED IN LITHOTOMY POSITION IN O.R., THE RLE STIRRUP ON THE BED FAILED. THE PT WAS TRANSFERRED TO A STRETCHER WITHOUT INJURIES. ADVISED BY THE SALES REP, THAT THE PROBLEM WAS USER ERROR AS THE BED MUST HAVE BEEN PLACED IN REVERSE TRENDELENBURG POSITION THAT CAUSED THE PELVIC AREA OF THE BED TO STRIKE THE BOTTOM FRAME, THEREBY DAMAGING THE BED AND RESULTING IN THE DESCRIBED FAILURE. SINCE REVERSE TRENDELENBURG IS A POSITIONING YOU WOULD EXPECT THIS BED TO SAFELY PROVIDE, HOSP CONSIDERS THIS A DESIGN FLAW OF THE BED THAT SHOULD BE CORRECTED TO PREVENT FURTHER OCCURRENCES THAT COULD RESULT IN PT INJURY.

Description of Event or Problem · 1

ADD'L INFO REC'D FROM MFR 03/12/05: AFTER THOROUGHLY INVESTIGATING THIS INCIDENT, IT IS THE POSITION OF TRUMPF THAT THIS INCIDENT WAS THE RESULT OF USER ERROR. TO SUMMARIZE, THE TABLE GAVE THE USER INDICATIONS THROUGH AN AUDIBLE BEEP THAT AN IMMOVABLE OBJECT WAS PREVENTING THE TABLE TO PERFORM PROPERLY. THESE INDICATION WERE IGNORED BY THE USER AND THE END RESULT WAS A BROKEN ACCESSORY. SINCE THIS INCIDENT, THE HOSP STAFF WAS GIVEN ANOTHER IN-SERVICE TO INSTRUCT THEN HOW TO USE THE TABLE PROPERLY AS WELL AS A REPLACEMENT ACCESSORY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TRUMPF TITAN OR TABLE	OPERATING ROOM TABLE	FQO	TRUMPF MEDICAL SYSTEMS, INC.	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Other