FDA Adverse Event
Death
Summary report: N
OXIMAX N600X PULSE OXIMETER
MDR report key: 4042201
·
Received July 21, 2014
Report
- Report Number
- 2936999-2014-00653
- Event Type
- Death
- Date Received
- July 21, 2014
- Date of Event
- June 14, 2014
- Report Date
- June 25, 2014
- Manufacturer
- COVIDIEN
- Product Code
- DQA
- PMA / PMN Number
- K123581
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
COVIDIEN CURRENTLY HAS THE DEVICE, AND THE INVESTIGATION IS IN PROGRESS. (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION REPORTING THE DEATH OF A PATIENT WHO WAS BEING MONITORED BY AN N-600X PULSE OXIMETER. THE MOTHER OF THE PATIENT REPORTED THE DEATH TO THE HOME-CARE EQUIPMENT PROVIDER (PEDIATRIC HOME SERVICE). THE MOTHER OF THE PATIENT REPORTED THAT SHE DID NOT KNOW WHETHER THE AUDIBLE ALARM DID NOT SOUND OR WHETHER THE ALARM SOUNDED BUT SHE DID NOT HEAR IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426867 | OXIMAX N600X PULSE OXIMETER | PULSE OXIMETER | DQA | COVIDIEN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Death |