MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 630

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Head Injury (1879); Unspecified Tissue Injury (4559)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

Udi not required.Legal manufacturer: hcs buc - (b)(4).

Event Description

On (b)(6) 2022 during the installation of an innova igs 630 system, the gehc field service engineer was in the exam room working on the installation of monitor suspension of an innova igs 630 system.He climbed a ladder and get unbalanced and fell with a cover of the suspension in his hand.During his fall, his head hit the cover and get injured.

Manufacturer Narrative

Based on the investigation, there was no issue with the system.The service staff member who suffered serious injury didn't follow the instructions while executing maintenance on the system what was not in operation that time.It is an isolated case, training will be organized to field engineers as a preventive action.

Event Description

On february 25, 2022 during the installation of an innova igs 630 system, the gehc field service engineer was in the exam room working on the installation of monitor suspension of an innova igs 630 system.He climbed a ladder and get unbalanced and fell with a cover of the suspension in his hand.During his fall, his head hit the cover and get injured.

• Brand Name: INNOVA IGS 630
• Type of Device: INNOVA IGS 630
• 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: 13868402
• MDR Text Key: 291294989
• Report Number: 9611343-2022-00001
• Device Sequence Number: 1
• Product Code: OWB
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 06/23/2022
• 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: A
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 67 KG