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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA / DELTA XL; PHYSIOLOGICAL MONITORING SYSTEMS
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DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA / DELTA XL; PHYSIOLOGICAL MONITORING SYSTEMS Back to Search Results
Device Problem Material Twisted/Bent (2981)
Patient Problems Skin Discoloration (2074); Swelling (2091); Injury (2348)
Event Date 09/27/2019
Event Type  Injury  
Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
 
Event Description
It was reported that a patient injury was noted after a 4-5 hour surgery during which the nibp cuff remained, unused, on the patient (right arm).The hose of the cuff was deliberately disconnected from the delta device during surgery as ibp was being used (on the left arm).During the operation, the patient's right arm was covered with the operating sheet so no personnel observed the arm.Once the surgery was completed it was noted that the right forearm was severely discolored and swollen with a clear one demarcation at the lower part of the cuff.It is not clear from interview with staff whether the cuff was inflated or not when the injury was noted.Though the involved delta monitor, nibp cuff and hose remained in use, a month later, testing was performed with no malfunctions identified.The site recreated a scenario stating that if the cuff had been in an inflated state when the hose was unplugged from the delta monitor and the hose was bent, the cuff may have remained inflated resulting in the injury.The patient was assessed and diagnosed with compartmental syndrome which is managed by a hand surgeon.Persistent disability in the patient's dominant right arm / hand is expected.
 
Event Description
It was reported that a patient injury was noted after a 4-5 hour surgery during which the nibp cuff remained, unused, on the patient (right arm).The hose of the cuff was deliberately disconnected from the delta device during surgery as ibp was being used (on the left arm).During the operation, the patient's right arm was covered with the operating sheet so no personnel observed the arm.Once the surgery was completed it was noted that the right forearm was severely discolored and swollen with a clear one demarcation at the lower part of the cuff.It is not clear from interview with staff whether the cuff was inflated or not when the injury was noted.Though the involved delta monitor, nibp cuff and hose remained in use, a month later, testing was performed with no malfunctions identified.The site recreated a scenario stating that if the cuff had been in an inflated state when the hose was unplugged from the delta monitor and the hose was bent, the cuff may have remained inflated resulting in the injury.The patient was assessed and diagnosed with compartmental syndrome which is managed by a hand surgeon.Persistent disability in the patient's dominant right arm / hand is expected.
 
Manufacturer Narrative
Additional information regarding the status of the patient was requested but no further information was provided.It was confirmed that the hospital biomed¿s investigation identified the cause as the nibp cuff hose being deliberately unplugged from the delta monitor (as per site protocol when ibp is used during surgery/a disconnect alarm was provided).The hose was inadvertently bent while the cuff remained on the patient at least partially inflated.The arm was covered and not checked during the 4-5 hour surgery.The delta instructions for use warns users to make sure that hose is not compressed or kinked and to check the cuff site regularly to prevent cuff pressure from impeding the blood flow.As the cuff hose was disconnected from the delta prior to surgery, the device did not play a factor in this event.However, the delta was tested by the biomed with no malfunctions identified and remains in use.The involved cuff and hose remain in use, in circulation with the other cuffs and hoses and therefore, cannot be identified for testing.However, the biomed noted that the staff was paying extra attention and no issues have been reported for any of the cuffs or hoses in use.No draeger device malfunction was identified.Therefore, draeger can confirm our device was not a factor in this injury.This is an isolated case.
 
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Brand Name
INFINITY DELTA / DELTA XL
Type of Device
PHYSIOLOGICAL MONITORING SYSTEMS
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC
6 tech drive
andover MA 01810 2434
MDR Report Key9519834
MDR Text Key188217056
Report Number1220063-2019-00028
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K152407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/12/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received12/12/2019
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
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