MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number M3001A-68402

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem Hypoxia (1918)

Event Date 03/10/2017

Event Type  malfunction  

Event Description

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.

• Brand Name: PHILIPS
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 6416826
• MDR Text Key: 70336834
• Report Number: 6416826
• Device Sequence Number: 1
• Product Code: DXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M3001A-68402
• Device Catalogue Number: 862442
• Other Device ID Number: 453563486941
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR