MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for PHILIPS M3001A-68402 862442 manufactured by Philips Medical Systems.
[70336833]
Patient Sequence No: 1, Text Type: N, H10
[70336834]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6416826 |
| MDR Report Key | 6416826 |
| Date Received | 2017-03-20 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-03-10 |
| Report Date | 2017-03-10 |
| Date Reported to FDA | 2017-03-10 |
| Date Reported to Mfgr | 2017-03-10 |
| Date Added to Maude | 2017-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS |
| Generic Name | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY |
| Product Code | DXH |
| Date Received | 2017-03-20 |
| Model Number | M3001A-68402 |
| Catalog Number | 862442 |
| ID Number | 453563486941 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-20 |