|
Model Number BABYTHERM 8000 WB |
Event Date 07/23/1997 |
Event Type
Malfunction
Patient Outcome
Other;
|
Event Description
|
It was reported that a restless and strong baby lifted and opened one side panel.
|
|
Manufacturer Narrative
|
Drager intesively investigated the type of devices involved in the event.
The user manual recommended to use the add'l inner panels of the babytherm 8000 to protect the baby from falling out of the babytherm.
In the reported event a very active and strong baby was lying in the heated bassinet.
Drager medizintechnick gmbh decided to clarify the statement in the user manual mentioned above and will recommend to always use the inner panels with active infants.
The customers will also be informed by drager.
|
|
Search Alerts/Recalls
|
|
|
Brand Name | BABYTHERM 8000 |
Type of Device | HEATED BASSINET |
Baseline Brand Name | BABYTHERM 8000 |
Baseline Generic Name | HEATED BASSINET |
Baseline Catalogue Number | FR 00048 |
Baseline Model Number | BABYTHERM 8000 WB |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
DRAGER |
moislinger allee 53-55 |
luebeck |
GERMANY
23542
|
|
Manufacturer (Section D) |
DRAGER |
moislinger allee 53-55 |
luebeck |
GERMANY
23542
|
|
Manufacturer (Section G) |
DRAEGER MEDICAL AG & CO. KG |
53/55 moislinger allee |
|
luebeck |
GERMANY
23542
|
|
Device Event Key | 115063 |
MDR Report Key | 117324 |
Event Key | 110325 |
Report Number | 9611500-1997-00008 |
Device Sequence Number | 1 |
Product Code | FMT |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/28/1997 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 08/28/1997 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device MODEL Number | BABYTHERM 8000 WB |
Device Catalogue Number | FR 00048 |
Was Device Available For Evaluation? |
Yes
|
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/29/1997 |
Distributor Facility Aware Date | 08/28/1997 |
Device Age | 4 mo |
Event Location |
Hospital
|
Date Manufacturer Received | 08/14/1997 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 05/01/1997 |
Is The Device Single Use? |
No
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Reuse
|
|
|
Database last updated on January 30, 2009
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