XPRT SLEEP SURFACE 2950000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-24 for XPRT SLEEP SURFACE 2950000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[4261256] It was reported via repair work order that the top cover was damaged with fluid intrusion. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


[4528003] It was reported via repair work order that the top cover was damaged with fluid intrusion. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


[11605427] Conclusion: parts on order.
Patient Sequence No: 1, Text Type: N, H10


[11902724] Follow-up submitted to report the mattress cover was replaced.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001831750-2014-02602
MDR Report Key3696184
Report Source06
Date Received2014-03-24
Date of Report2014-02-28
Date of Event2014-02-28
Date Mfgr Received2014-02-28
Date Added to Maude2014-03-25
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 FDA0
Event Location0
Manufacturer ContactMR. PRAVIN BETALA
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 NameXPRT SLEEP SURFACE
Generic NameCOVER, MATTRESS (MEDICAL PURPOSES)
Product CodeFMW
Date Received2014-03-24
Catalog Number2950000000
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-24

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