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

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).

Manufacturer Narrative

Based on the gehc engineering's investigation, no device problem has been found.The hazardous situation is a partial entrapment of the nurse leg between the l-arm and the motorized c-arm which lead to a serious injury (skin tear).The ongoing exam was successfully finished.Cause of the event is user error, lack of knowledge of moving parts handling.No similar event has happened during the last 3 years.No additional corrections, corrective, or preventive actions were identified during the course of the investigation.

Event Description

As a result of uncontrolled motion, hospital employee was trapped and injured by moving part.

• Brand Name: INNOVA 3100 CARDIO HARMONY
• Type of Device: INNOVA 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 Key: 14945049
• MDR Text Key: 295422495
• Report Number: 9611343-2022-00003
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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 Received: 06/14/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female