FDA Adverse Event
Malfunction
Summary report: N
CLINICAL INFORMATION CENTER
MDR report key: 1133447
·
Received August 22, 2008
Report
- Report Number
- 2124823-2008-00070
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- July 28, 2008
- Report Date
- August 22, 2008
- Manufacturer
- GE HEALTHCARE
- Product Code
- DSI
- PMA / PMN Number
- K053356
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PATIENT WAS UNINTENTIONALLY REMOVED FROM A SLOT ON A CIC, THEN REAPPEARED APPROXIMATELY 10 MINUTES LATER. DURING THE 10 MINUTE TIME, A PATIENT HAD A HIGH HEART RATE AND THE CIC DID NOT ALARM AUDIBLY. NO PATIENT DEATH OR INJURY OCCURRED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINICAL INFORMATION CENTER | CENTRAL MONITORING SYSTEM | DSI | GE HEALTHCARE | 2019989-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |