N
Patient 1
MAUDE MDR 6416826
- MDR report key
- 6416826
- Report number
- 6416826
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-03-10
- Date received
- 2017-03-20
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PHILIPS | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | PHILIPS MEDICAL SYSTEMS | DXH | M3001A-68402 | 862442 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-20 | 0 |
Event Narratives#
D
Patient 1
ICU DOCTOR REPORTED: PHILLIPS PULSE OX MONITORS ARE NOT PROVIDING OXYGEN SATURATION DATA THAT CORRELATES WITH ARTERIAL BLOOD GAS OXYHEMOGLOBIN MEASUREMENT/PO2. AS A RESULT, PATIENTS ARE INADVERTENTLY BEING ALLOWED TO BE HYPOXEMIC AND OXYGEN SUPPLEMENTATION IS NOT BEING APPROPRIATELY TITRATED UP. ONE DAY, THE DISCREPANCY BETWEEN PULSE OX (94-95%) AND ABG (73%) WAS SEEN AND THOUGHT TO BE A FLUKE. THE PATIENT'S OXYGEN WAS TITRATED UP. CHARGE NURSES WERE NOTIFIED OF MONITOR DISCREPANCY. THE NEXT DAY, THE MORNING ABG REVEALED A O2HGB SATURATION OF 73.4% DESPITE PHILLIPS PULSE OXIMETRY OF 100%. DOCTOR DISCUSSED WITH THE RESPIRATORY MANAGER: RT MANAGER ADVISED THAT THIS PROBLEM HAD BEEN IDENTIFIED AS INACCURATE PULSE OXIMETRY MEASUREMENTS BY THE PHILLIPS PULSE OXIMETRY UNITS. ACCORDING TO RESPIRATORY MANAGER, THIS PROBLEM HAD BEEN IDENTIFIED PREVIOUSLY AND TRACKED/CONFIRMED WITH CONCOMITANT ARTERIAL BLOOD GAS READINGS FOR MASIMO & PHILLIPS MEASUREMENTS AND DICTATING THAT THE PHILIPS PULSE OXIMETRY UNITS HAVE A LARGER MARGIN OF ERROR COMPARED TO MASIMO.