GIRAFFE OMNIBED
Report
- Report Number
- 3005860720-2022-00011
- Event Type
- Malfunction
- Date Received
- April 20, 2022
- Date of Event
- March 22, 2022
- Report Date
- December 13, 2022
- Manufacturer
- GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC
- Product Code
- FMZ
- PMA / PMN Number
- K071175
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
GE HEALTHCARE MAINTENANCE TECHNICAL ASSISTANT DISMANTLED THE CANOPY SEALS AND REASSEMBLED THEM AFTER THE CANOPY SEALS WERE CLEANED BY THE CUSTOMER AS RECOMMENDED IN THE USER MANUAL. THERE WAS NO PATIENT IMPACT AND THERE WAS NO PRODUCT MALFUNCTION IDENTIFIED. H3 OTHER TEXT : GE HEALTHCARE MAINTENANCE TECHNICAL ASSISTANT DISMANTLED THE CANOPY SEALS AND REASSEMBLED THEM AFTER THE CANOPY SEALS WERE CLEANED BY THE CUSTOMER AS RECOMMENDED IN THE USER MANUAL. THERE WAS NO PATIENT IMPACT AND THERE WAS NO PRODUCT MALFUNCTION IDENTIFIED.
THE HOSPITAL REPORTED AN ALLEGATION OF MOLD ON THE CANOPY SEALS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1089067 | GIRAFFE OMNIBED | INCUBATOR, NEONATAL | FMZ | GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |