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

Model Number M3002A

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2022

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation reporting institution phone number: (b)(6).

Event Description

The following was reported: the monitor did not generate an alarm for a patient on (b)(6) 2022 at 09:23.The patient had to be resuscitated.

Event Description

Statement of the reported problem: this report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the intellivue multi measurement server x2 indicating that the device failed to alarm properly.It was reported that at the time of the event the device was being used to monitor a child patient.The patient required resuscitation.A good faith effort was completed to acquire additional information about the event, but the respondent indicated the customer was unwilling to provide further details.Functional testing/service repair/technical investigation: the following functional tests were performed: no functional test were completed because the customer refused further service.The customer indicated ¿the incident did not occur exactly as it was initially reported, therefore nothing has to be checked and the question can be cancelled.¿ confirmation: based on the information available, the cause of the reported problem is undetermined.The reported problem could not be confirmed because the customer refused further assistance.Further action decision: based on the information available, no further action is necessary at this time.Closure & product disposition: we are unable to confirm the final disposition of the device because the customer refused service and declined to provide additional information.The investigation concludes that no further action is required at this time.

Manufacturer Narrative

H3 other text : customer refused service.

• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 15594816
• MDR Text Key: 301638958
• Report Number: 9610816-2022-00520
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3002A
• Device Catalogue Number: M3002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2008
• 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
• Patient Outcome(s): Required Intervention; Life Threatening