FDA Adverse Event
Death
Summary report: N
MC10 PULSE OXIMETRY CABLE
MDR report key: 337342
·
Received June 15, 2001
Report
- Report Number
- 8043756-2001-00002
- Event Type
- Death
- Date Received
- June 15, 2001
- Report Date
- June 15, 2001
- Manufacturer
- NELLCOR DE MEXICO, S.A. DE C.V.
- Product Code
- DQA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON 5/16/2001, A FACILITY REPORTED THAT IN 2000 A NELLCOR PULSE OXIMETER ON PT ALARMED (DISPLAYING A "SENSOR DISCONNECT MESSAGE"). THE FACILITY REPORTEDLY IGNORED THE ALARM. THE FACILITY ALSO REPORTED THAT THE PT DESATURATED, SUFFERED ANOXIA AND SUBSEQUENTLY DIED. THIS INFO WAS REPORTED TO A MALLINCKRODT EMPLOYEE DURING A VISIT TO THE FACILITY AND A DISCUSSION REGARDING DIFFICULTIES REPORTED BY THE FACILITY CONCERNING LOOSE MC-10 PULSE OXIMETER CABLES (WHICH CONNECT THE SENSOR TO THE MONITOR). THE LOOSE CABLES RESULTED IN FREQUENT MONITOR ALARMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27299 | MC10 PULSE OXIMETRY CABLE | PULSE OXIMETRY CABLE | DQA | NELLCOR DE MEXICO, S.A. DE C.V. | MC10 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death | 1. NPB 290| 2. OXINET II SYSTEM. |