MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS M3002 X2 OPTION A01C06 MONITOR/MODULE; MULTIMEASUREMENT SPO2 PULSE OXIMETRY MODULE

Model Number SPO2 PULSE OXIMETRY MODULE

Device Problems Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found that the case was cracked.Technical visual inspection found no anomalies.Device evaluation identified that there was an spo2 malfunction.The spo2 pcb board was replaced.The software options were set to c00 c01 c13 c15 c20.The software was set to k.21.58.The circuit boards were inspected.The nibp was calibrated.The device was tested on a simulator and the display, ecg, ibp, network lan/wlan, nibp, on/off, spo2, and temp tests all passed.It was determined that this was related to the previous repair.The root cause was determined to be a broken coil.This type of event will continue to be monitored.

Event Description

Reportedly, post repair the device will not read spo2.There was no patient involvement.No additional information is available.

• Brand Name: PHILIPS M3002 X2 OPTION A01C06 MONITOR/MODULE
• Type of Device: MULTIMEASUREMENT SPO2 PULSE OXIMETRY MODULE
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; hewlett-packard-str.-2; boeblingen, 71034 ; GM 71034
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672
• MDR Report Key: 9247799
• MDR Text Key: 178001940
• Report Number: 3007409280-2019-00065
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPO2 PULSE OXIMETRY MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1