ISOLIBRIUM SUPPORT SURFACE - N 2971000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-10 for ISOLIBRIUM SUPPORT SURFACE - N 2971000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[107892478] The nurse manager indicated she believed the injury may be attributed to the mattress cycling out of prevention mode. She was informed by a stryker quality assurance engineer that the mattress may leave prevention mode if the power of the unit is cycled and patient therapy settings are not reselected. The nurse manager reported the account is working on training measures to educate nurses to check to make sure the bed is in prevention mode. No device malfunction is alleged.
Patient Sequence No: 1, Text Type: N, H10


[107892479] It was reported the patient developed a stage 3 pressure injury while on the mattress. The nurse manager reported the injury was treated using venelex.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2018-00470
MDR Report Key7503572
Report SourceUSER FACILITY
Date Received2018-05-10
Date of Report2018-05-10
Date of Event2018-04-11
Date Mfgr Received2018-05-08
Date Added to Maude2018-05-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MARY KLAVER
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693292100
Manufacturer G1STRYKER MEDICAL-KALAMAZOO
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal Code49002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameISOLIBRIUM SUPPORT SURFACE - N
Generic NameBED, PATIENT ROTATION, POWERED
Product CodeIKZ
Date Received2018-05-10
Catalog Number2971000000
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-10

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