FDA Adverse Event
Malfunction
Summary report: N
CARESTATION 650
MDR report key: 19044724
·
Received April 4, 2024
Report
- Report Number
- 9710602-2024-00460
- Event Type
- Malfunction
- Date Received
- April 4, 2024
- Date of Event
- March 12, 2024
- Report Date
- April 4, 2024
- Manufacturer
- GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
- Product Code
- BSZ
- UDI-DI
- 00840682124560
- PMA / PMN Number
- K151570
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE BATTERY WAS REPLACED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS WUXI - NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE CHINA WUXI JIANGSU, 214028.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57997 | CARESTATION 650 | ANESTHESIA GAS MACHINE | BSZ | GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) | 00840682124560 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |