Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, LLC BLANKETROL; SYSTEM, THERMAL REGULATING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CINCINNATI SUB-ZERO PRODUCTS, LLC BLANKETROL; SYSTEM, THERMAL REGULATING Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)
Patient Problems Bradycardia (1751); Cardiopulmonary Arrest (1765); Hemorrhage/Bleeding (1888); Alteration In Body Temperature (2682)
Event Date 12/07/2016
Event Type  malfunction  
Event Description
Patient with hypoxic ischemic encephalopathy vs.Meconium aspiration syndrome on extracorporeal membrane oxygenation (ecmo) day 3.Reportedly, rn noticed patient temperature decreasing during 0440 lab draw.Rn increased temperature of radiant heat source.Around this time the infant began hemorrhaging frank red blood from endotracheal tube and became bradycardic.Code initiated at 0543.At approximately 0600 the perfusionist arrived at bedside and noted water bath not functioning.Rn attempted to take patient temperature.Temperature was unreadable.Water bath removed from service.A new machine was brought to the bedside.Investigation ongoing.
 
Event Description
Patient with hypoxic ischemic encephalopathy vs.Meconium aspiration syndrome on extracorporeal membrane oxygenation (ecmo) day 3.Reportedly, rn noticed patient temperature decreasing during 0440 lab draw.Rn increased temperature of radiant heat source.Around this time the infant began hemorrhaging frank red blood from endotracheal tube and became bradycardic.Code initiated at 0543.At approximately 0600 the perfusionist arrived at bedside and noted water bath not functioning.Rn attempted to take patient temperature.Temperature was unreadable.Water bath removed from service.A new machine was brought to the bedside.Investigation ongoing.After additional investigation, it was found that a safety mechanism shut the water bath off when a scheduled generator test was being performed throughout the hospital.Reportedly, lights on the device remained on but the water pump indicator on the side stopped rotating, meaning water was no longer being circulated.There were no alarms that signaled that the device was being shut down.The shutdown of the device went unnoticed for approximately 1 hour which caused the patient¿s temperature to decrease after which the above events occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BLANKETROL
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
CINCINNATI SUB-ZERO PRODUCTS, LLC
12011 mosteller rd.
cincinnati OH 45241
MDR Report Key6266025
MDR Text Key65357438
Report Number6266025
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Other Device ID Number14089
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2016
Device Age11 YR
Event Location Hospital
Date Report to Manufacturer12/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Weight3
-
-