MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2

Model Number M3002A

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

The customer reported that the sp02 reading not accurate.It is unknown if the device was in use.No adverse event to the patient or user was reported.

Manufacturer Narrative

Reporter phone number (b)(6).A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

H3 other text : see b5.

Event Description

It was reported that the oxygen saturation (spo2) reading was not accurate.It is unknown if the device was in use.No adverse event to the patient or user was reported.A philips response service engineer (rse) spoke to the customer.Customer was provided a quote for onsite services but has not accepted the quote; therefore the cause cannot be determined at this time.It is unknown how this issue was resolved.The customer has refused further support; therefore the cause cannot be determine at this time.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15663637
• MDR Text Key: 302476548
• Report Number: 9610816-2022-00537
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M3002A
• Device Catalogue Number: M3002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2014
• 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