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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; SYSTEM, THERMAL REGULATING
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number UNK_MED
Device Problem Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2020
Event Type  malfunction  
Event Description
It was reported via a troubleshooting call that the device had a temperature deviation alarm.The patient was in a rewarming phase on auto mode set to rewarm the patient at 0.5 degrees/hour until the goal temperature of 36.5c was reached.The nurse alleged that patient was rewarming slower than the desired rate.Approximately 6 hours into warming, the axillary temperature read 36.1c, and the esophageal probe read 35.4c.The nurse reported the probe was connected properly and had not been moved.The nurse also stated that no blankets had been removed, and the patient's condition had not changed.The water temperature was 40.1c.
 
Manufacturer Narrative
The investigation concluded that the cause of the reported event could not be determined, as the customer did not make the device available for evaluation and declined any further troubleshooting.
 
Event Description
It was reported via a troubleshooting call that the device had a temperature deviation alarm.The patient was in a rewarming phase on auto mode set to rewarm the patient at 0.5 degrees/hour until the goal temperature of 36.5c was reached.The nurse alleged that patient was rewarming slower than the desired rate.Approximately 6 hours into warming, the axillary temperature read 36.1c, and the esophageal probe read 35.4c.The nurse reported the probe was connected properly and had not been moved.The nurse also stated that no blankets had been removed, and the patient's condition had not changed.The water temperature was 40.1c.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10844215
MDR Text Key220238607
Report Number0001831750-2020-01204
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_MED
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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