To all operators and users
of
Babytherm 8004/8010 open care units
for premature and newborn patients
lmportant safety notice!l!
Babytherm 8004/8010
open care units for premature and newborn patients
Dear Madam/Sir,
Dräaer
June 2016
As part
of
our market and product monitaring we have become aware
of
a case
in
which
a Babytherm
8004 without patient was operated
in
skin temperature mode with skin
temperature sensor to prepare it for use. ln skin temperature mode, the radiant warmer
output is controlled automatically until the set skin temperature
is
reached. As a result
of
operating the temperature sensor without patient contact, the radiant warmer was
operated continuously at a high output
Ievel. During this forced continuous operation
under high thermal
Ioad, the heating element aged faster.
Apart
became detached from
the heating element and fell onto the mattress tray
\1\fhere
a towel caught fire.
Do not operate the device
in
skin temperature mode with temperature sensor
without patient contactl
To preheat the device, you can use the manual mode up to
Ievel 3 as there is no active
time
Iimit. At Ievel 4 or above, there will be regular alarms.
lf
the alarm
is
not
acknowledged, the radiantwarmer will
be
automatically switched off. For further details,
please refer to the Babytherm
8004/8010 instructions for use.
Additionally, our analyses have shown that the heating elements are not replaced at
regular intervals as recommended
in
the Babytherm instructions for use. We attribute this
to the fact that it might not
be
practicable to replace the heating element after 10,000
operating hours. We have therefore converted this value into a period
of
2 years, which
can
be
measured more easily.
lf your heating elements have been in operation for more than 2 years,
please
replace them.
Drägerwerk
AG
& Co. KGaA
Mo
islinger Allee 53-55
23558 Lübeck, Germany
Postal address:
23542 Lübeck, Germany
TeL
+49
451
882.{)
Fax +49
451
882-2080
info@draeger.com
www.draeger.com
VAT
ID
DE135082211
Bank information: Company headquarters: Lübeck
Commerzbank
AG,
Lübeck Commercial register:
IBAN:
DE95 2304 0022 0014 6795 00 Municipal Court
lübeck
HRB 7903
HL
Swift Code: COBA
OE
FF
230 General partner: Drägerwerk Verwaltungs
Sparkasse
zu
Lübeck
AG
IBAN:
DE15 2305
0101
0001
0711
17 Company headquarters: Lübeck
Swift code: NOLADE21SPL Commercial
reg
ister:
Municipal Court Lübeck HRB 7395
HL
Chairman of the Executi
ve
Board
for
Drägerwerk
AG
&
Co
. KGaA
and
Drägerwerk Verwaltungs
AG
:
Prof. Dr.
Nikolaus Schweickart
Executive Board:
Siefan Dräger (Chairman)
Rainer
Klug
Gert-Hartwig Lescow
Dr. Reiner Piske
Anton Schrofner
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