EZ DEFLATE PRESSURE CUFF 7204017

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-06 for EZ DEFLATE PRESSURE CUFF 7204017 manufactured by Smiths Medical Asd, Inc.

Event Text Entries

[182524716] The event date is an approximate date. Only the month ((b)(6)) and year (2019) are known. Evaluation results: one ez deflate pressure cuff was returned for investigation. Upon visual inspection, the investigator observed that the pressure chamber had a loose hose. There was also a crack on the pressure chamber door. The unit was losing pressure due to the aforementioned reasons. The door was replaced and the loose tubing was adjusted. The ez deflate pressure cuff was subsequently connected to the one level 1 trauma fast flow system. The desired pressure of 289 mmhg was then achieved on the one level 1 trauma fast flow system. The customer reported product problem was therefore replicated. The problem source of the reported product problem was unknown. A root cause was not established.
Patient Sequence No: 1, Text Type: N, H10


[182524718] It was reported pressure chambers infused only 60 percent of the infusion bag in five minutes. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01711
MDR Report Key9802702
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-03-06
Date of Report2020-03-06
Date of Event2019-06-01
Date Mfgr Received2020-02-06
Device Manufacturer Date2018-12-03
Date Added to Maude2020-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer G1SMITHS MEDICAL ASD, INC
Manufacturer Street3350 GRANADA AVENUE NORTH SUITE 100
Manufacturer CityOAKDALE, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEZ DEFLATE PRESSURE CUFF
Generic NameWARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Product CodeBSB
Date Received2020-03-06
Returned To Mfg2019-08-13
Catalog Number7204017
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.