ACUSON SEQUOIA
Report
- Report Number
- 3023245-2024-00048
- Event Type
- Injury
- Date Received
- July 26, 2024
- Date of Event
- November 10, 2022
- Report Date
- January 29, 2025
- Manufacturer
- SIEMENS HEALTHINEERS
- Product Code
- IYN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
REFERENCE# (B)(4).
THE INITIAL MDR (MFR# 3023245-2024-00048) WAS SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS. THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RELATED TO THE INVESTIGATION RESULTS. IN THIS CASE, THE CUSTOMER REPORTED THAT THERE WAS A CRACK IN THE PLASTIC NEAR THE FRONT HANDLES WHICH LED TO A MINOR CUT ON THE SONOGRAPHER'S FINGER ON THIS IN WHILE PRESSING THE LOCK RELEASE. IT WAS CONFIRMED THAT THERE WAS NO MEDICAL INTERVENTION NEEDED FOR THE CUT. THE COVER UNDER FRONT HANDLE ASSY WAS REPLACED AND THE ISSUE HAS NOT RECURRED. A SEARCH WAS PERFORMED IN THE SERVICE AND COMPLAINTS DATABASE (GSMS AND SMARTSOLVE) AND NO OTHER RELATED ISSUES WERE FOUND FOR THIS SYSTEM. IT COULD NOT BE DETERMINED HOW THE PLASTIC WAS BROKEN BASED ON AVAILABLE INFORMATION. NO TRENDS WERE FOUND FOR THIS ISSUE. REFERENCE# (B)(4).
THERE IS A CRACKED SMALL PLASTIC PANEL UNDERNEATH THE FRONT HANDLES OF ONE OF OUR SEQUOIA ULTRASOUND MACHINES AND ONE OF OUR SONOGRAPHER RECENTLY CUT HIS FINGER ON THIS IN WHILE PRESSING THE LOCK RELEASE BUTTONS NEAR IT. THIS MDR IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459942 | ACUSON SEQUOIA | ULTRASOUND DEVICE | IYN | SIEMENS HEALTHINEERS | 11148775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |