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

Model Number M8105A

Device Problem Defective Alarm (1014)

Patient Problem Hypoxia (1918)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the system did not alarm on a severe desaturation (severe hypoxia, the baby was blue, the patient has been placed on oxygen).

Manufacturer Narrative

The remote service engineer (rse) spoke to the customer and pulled the logs.¿to access the blocked audio and visual menu, you need to go in the main config then alarm then alarm settings: visual blocked and audio not blocked.In our case, the red desaturation alarm is generated at 20:32 and 36 seconds, it was never acknowledged until 21:46 and 29 seconds.Since the first alarm of 20:32 and 36 seconds was not acknowledged, not only is the second alarm not listed in the alarm review or in the audit log of the central station, but no recording is available for this alarm.Moreover, the mp5 is configured in blocked visual mode and audio not blocked, so the reappearance of the alarm condition generated a new audio alarm and the corresponding alarm indicator flashed but since the first alarm was never acknowledged, there is no trace in the logs." based on the information available and the testing conducted, the device was functioning as intended and there is no malfunction on the device.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 16918521
• MDR Text Key: 315077783
• Report Number: 9610816-2023-00220
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: M8105A
• Device Catalogue Number: M8105A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2011
• 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