ORS-320 SLUSH WARMER DISC DRAPE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-22 for ORS-320 SLUSH WARMER DISC DRAPE manufactured by Microtek Dominicana, S.a..

Event Text Entries

[93297313] No samples were returned for this investigation. The dhr was reviewed for this lot and it was noticed that (b)(4) pieces were manufactured from 03/22/2017 to 03/23/2017. No defects were reported during quality inspection. Based on the dhr review this does not appear to be the result of a personnel, process or material issue. Melts, though uncommon, can occur when the warmer is not draped properly, not turned off by using the power button, and/or there is insufficient fluid in the warmer basin, contrary to the operations manual, product labeling, product insert and in-service presentations. Because no sample was provided and the non conformance could not be confirmed, no additional actions will be taken at this time. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[93297314] End user reported that upon cleaning up from a surgical case, there was a significant amount of water found in the warmer underneath the drape with an accompanying small hole in the warmer drape this was not noticed during the surgical procedure. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8043817-2017-00030
MDR Report Key7052808
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-11-22
Date of Report2017-10-24
Date of Event2017-08-08
Date Mfgr Received2017-10-24
Date Added to Maude2017-11-22
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 ContactMRS JENNIFER MRKVICKA
Manufacturer Street1 ECOLAB PLACE
Manufacturer CityST. PAUL MN 55102
Manufacturer CountryUS
Manufacturer Postal55102
Manufacturer Phone6512502237
Manufacturer G1MICROTEK DOMINICANA
Manufacturer StreetZONA FRANCA NO. 2
Manufacturer CityLA ROMANA,
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORS-320 SLUSH WARMER DISC DRAPE
Generic NameFLUID WARMING AND SLUSH DRAPES
Product CodeLHC
Date Received2017-11-22
Model NumberORS-320
Lot NumberD170811
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMICROTEK DOMINICANA, S.A.
Manufacturer AddressZONA FRANCA NO. 2 LA ROMANA, DR


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-22

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