MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-03 for HP PHILIP CENTRAL M315OA PULSE OXIMETER manufactured by Philips.
[2346464]
Pt was in intensive care unit on monitors: the abg in the morning was within normal limits. A second abg was taken and came at 74%, however, the hp phillips central m315oa pulse oximeter was reading 100%. A portable oximetry system was placed on pt and a 74% oxygen level was noted as a double check. Dates of use: (b)(6) 2001 - (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022503 |
| MDR Report Key | 2281566 |
| Date Received | 2011-10-03 |
| Date of Report | 2011-10-03 |
| Date of Event | 2011-09-27 |
| Date Added to Maude | 2011-10-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HP PHILIP CENTRAL M315OA PULSE OXIMETER |
| Generic Name | PULSE OXIMETER |
| Product Code | OLK |
| Date Received | 2011-10-03 |
| Model Number | M315OA |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2011-10-03 |