MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

Model Number 865024

Device Problem Defective Alarm (1014)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

Reporting institution phone #: na.Reporter phone #: (b)(6).A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

It was reported that on august 9th at 13:10 there was no alarm when the heart rate and blood oxygen saturation were lower than the set alarm limit.There was patient harm reported.

Event Description

Philips received a complaint on the intellivue mp5 indicating that the device failed to provide an audible alarm during a low heart rate and low spo2 event.The intellivue mp5 showed that the patient¿s heart rate was 90 times/minute.The heart rate low alarm limit was set to 100.The patient¿s percutaneous blood oxygen saturation was 70%.The spo2 low alarm limit was set to 85.As a result of the event the patient skin color turned pale and their reaction was poor.So, the resuscitation capsule was immediately connected to the positive pressure ventilation of the tracheal tube, and the respiratory secretions were cleaned.After treatment, the skin color of the patient turned red, and the vital signs monitored by the intellivue mp5 returned to normal.The following functional tests were performed: the alarm settings were checked for all intellivue mp5 monitors and central stations in the department.The alarm settings were normal.The customer was unable to confirm which of their intellivue mp5 devices was associated with the event.Event logs and configuration files were not available for review because they were not retained.But, following the event all of their intellivue mp5 have alarmed as expected.Per good faith effort response, it's possible that the device produced an alarm that was subsequently silenced at the central station.However, this remains unconfirmed.Results of functional testing could not conclude a root cause of the reported issue due to insufficient information.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported device issue could not be confirmed due to insufficient information.The device is alarming appropriately currently per good faith effort response.

Manufacturer Narrative

H3 other text : device not returned.

• Brand Name: INTELLIVUE MP5
• Type of Device: INTELLIVUE MP5
• 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: 15885383
• MDR Text Key: 304510034
• Report Number: 9610816-2022-00609
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• 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: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening
• Patient Age: 19 DA
• Patient Sex: Male