FDA Adverse Event
Malfunction
Summary report: N
OLYMPIC COOL-CAP SYSTEM
MDR report key: 2449533
·
Received February 1, 2012
Report
- Report Number
- 3018859-2012-00001
- Event Type
- Malfunction
- Date Received
- February 1, 2012
- Date of Event
- January 4, 2012
- Report Date
- February 1, 2012
- Manufacturer
- NATUS MEDICAL INCORPORATED
- Product Code
- MXM
- PMA / PMN Number
- P040025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NATUS MEDICAL INCORPORATED WILL SUBMIT A FOLLOW-UP REPORT TO FDA WHEN THE DEVICE INVESTIGATION / TESTING IS COMPLETED. (B)(4).
Description of Event or Problem · 1
INFANT BEING TREATED FOR NEONATAL HYPOXIC-ISCHEMIC ENCEPHALOPATHY WITH THE OLYMPIC COOL-CAP SYSTEM. APPROX 44 HOURS INTO TREATMENT, THE DEVICE EXHIBITED A SHUTDOWN CHARACTERIZED BY A FROZEN DISPLAY SCREEN. RECTAL TEMPERATURE WAS 35.5C WHEN ISSUE WAS DISCOVERED. DEVICE WAS REBOOTED AND TREATMENT CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPIC COOL-CAP SYSTEM | COOLING CAP (INFANTS) | MXM | NATUS MEDICAL INCORPORATED | 60010 | NOT APPLICABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |