FDA Adverse Event
Other
Summary report: N
DATEX-OHMEDA HMEF 500, DISPOSABLE
MDR report key: 618598
·
Received August 2, 2004
Report
- Report Number
- 9610105-2004-00011
- Event Type
- Other
- Date Received
- August 2, 2004
- Date of Event
- May 26, 2004
- Manufacturer
- INSTRUEMENTARIUM CORP.
- Product Code
- CAH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT WAS APPLIED WITH THE MECHANICAL VENTILATION IN HOME CARE. HMEF500 WAS USED. THE HIGH AIRWAY PRESSURE ALARM WAS ACTIVATED AFTER 2 OR 3 HOURS FROM STARTING VENTILATION. THIS DEFECTIVE HMEF500 WAS REPLACED AND THEN THE HIGH AIRWAY PRESSURE ALARM CEASED. BUT ANY FAILURE WAS NOT FOUND IN THIS DEFECTIVE HMEF500 BY ITS LOOKS. THE USING OF HMEF IS NORMAL ACCORDING TO THE INSTRUCTION OF USE. THIS PATIENT IS MRSA VICTIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DATEX-OHMEDA HMEF 500, DISPOSABLE | FILTER, BACTERIAL, BREATHING-CIRCUIT | CAH | INSTRUEMENTARIUM CORP. | NA | 30306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |