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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC SC7000/INFINITY DELTA PHYSIOLOGICAL MONITORING SYSTEM

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DRAEGER MEDICAL SYSTEMS, INC SC7000/INFINITY DELTA PHYSIOLOGICAL MONITORING SYSTEM Back to Search Results
Model Number 5203018E539U
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
Event Date 09/27/2017
Event Type  Injury  
Manufacturer Narrative

The investigation has started but has not been concluded. The outcome will be published in the follow up report.

 
Event Description

It was reported that from return of the operating room, arterial pressure values that were being measured via ibp dropped from 120 to 180 mmhg, then to 75 mmhg. A few minutes later, values grew again to 120 mmhg. The patient was treated for hypertension and hypotension.

 
Manufacturer Narrative

It was reported that from return of the operating room, arterial pressure values that were being measured via ibp dropped from 120 to 180 mmhg, then to 75 mmhg. A few minutes later, values grew again to 120 mmhg. The patient was treated for hypertension and hypotension.

 
Event Description

The customer reported fluctuating arterial pressure readings. The device and involved accessories were tested on site by a draeger service technician and the reported symptom could not be duplicated, no malfunction was identified. Therefore, no root cause could be determined.

 
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Brand NameSC7000/INFINITY DELTA
Type of DevicePHYSIOLOGICAL MONITORING SYSTEM
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC
6 tech drive
andover MA 01810 2434
Manufacturer Contact
dhaval trivedi
6 tech drive
andover, MA 01810-2434
MDR Report Key7003832
MDR Text Key91117549
Report Number1220063-2017-00058
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK152407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2000
Device MODEL Number5203018E539U
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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