FDA Adverse Event Other Summary report: N

INFANT INTENSIVE CARE SYSTEM

MDR report key: 1060561 · Received June 6, 2008

Report

Report Number: 2510954-2008-00006
Event Type: Other
Date Received: June 6, 2008
Date of Event: March 5, 2008
Report Date: June 6, 2008
Manufacturer: DRAEGER MEDICAL SYSTEMS, INC. (PNC)
Product Code: FMT
PMA / PMN Number: K875270
Report Source: Manufacturer report
Reporter Location: WY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

METHOD - THE BROKEN KNOBS WERE NOT RETURNED FOR EVAL. EVAL - IT COULD NOT BE DETERMINED HOW THE KNOBS WERE BROKEN. THE DEVICE DESIGN UTILIZES COMPONENT MATERIALS THAT ARE NOT PRONE TO BREAKAGE WITH NORMAL USE. THERE HAVE BEEN NO OTHER REPORTS OF THIS KNOB BREAKING, OR OF ANY INJURIES ASSOCIATED WITH A BROKEN KNOB. THE OPERATOR'S MANUAL "GENERAL OPERATIONS AND FUNCTIONAL CHECKOUT" SECTION DIRECTS THE USER TO INSPECT ASSEMBLIES FOR SIGNS OF BREAKAGE AND REPLACE ASSEMBLIES BEFORE PLACING A UNIT INTO SVC. THE DEVICE SHOULD NOT BE USED WITH BROKEN COMPONENTS. CONCLUSION - USER DID NOT REPLACE THE BROKEN COMPONENT BEFORE USING THE DEVICE.

Description of Event or Problem · 1

IT WAS REPORTED THAT: ON TWO WARMER UNITS, THE PLASTIC KNOB THAT IS MOUNTED ON THE THREADED SCREW WHICH SECURES THE E CYLINDERS IN THE UNIT BROKE WHILE MOVING THE WARMERS AROUND IN THE STORAGE ROOM. WHEN THE PLASTIC KNOB BROKE, IT BROKE IN SUCH A MANNER THAT LEFT A VERY SHARP EDGE. THE BIOMED AND HIS CO-WORKER HAD THEIR FINGERS "SLICED" BY THE SHARP PLASTIC ON THE KNOB. NO LONG TERM INJURY WAS SUSTAINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFANT INTENSIVE CARE SYSTEM	WARMER, INFANT RADIANT	FMT	DRAEGER MEDICAL SYSTEMS, INC. (PNC)	7880	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other