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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 3100 CARDIO HARMONY

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GE MEDICAL SYSTEMS SCS INNOVA 3100 CARDIO HARMONY Back to Search Results
Lot Number -
Device Problems Component Falling (1105); Sharp Edges (4013)
Patient Problem Laceration(s) (1946)
Event Date 06/14/2022
Event Type  Injury  
Event Description
The victim (nurse) was responding from the patient's head. While she was straddling the gantry her left foot was between the gantry arms. Since the operator did not notice and rotated the c arm toward the victim, the right side of the left knee fell down as if it were attached to the base, and the left knee was pinched by a sharp edge. It was a laceration. The victim was injured by suturing 5 needles around the center of the left knee. The treatment was temporarily suspended, but it was resumed immediately after the victim was rescued, so there is no significant time loss. There is no effect on the patient.
 
Manufacturer Narrative
Udi not required. Legal manufacturer: (b)(4).
 
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Brand NameINNOVA 3100 CARDIO HARMONY
Type of DeviceINNOVA 3100 CARDIO HARMONY
Manufacturer (Section D)
GE MEDICAL SYSTEMS SCS
283 rue de la miniere
buc 78530
FR 78530
Manufacturer (Section G)
GE MEDICAL SYSTEMS SCS
283 rue de la miniere
buc 78530
FR 78530
Manufacturer Contact
judit perjesi
283. rue de la miniere
buc 78530
FR   78530
MDR Report Key14945049
MDR Text Key295422495
Report Number9611343-2022-00003
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Lot Number-
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
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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