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

Model Number 865024

Device Problem Defective Alarm (1014)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

The customer reported the unit did not alarm when spo2 got below 72.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

A philips clinical specialist reviewed the log files provided.The following is based on the information provided.There was an alarm at 16:03:06 for spo2 81 less than 90.This alarm ended at 16:03:26 with the value of 79.There was and equipment change at 16:03:43.Looks like they added a x2 for transport.16:03:48 patient conflict was detected.16:03:50 no data monitor inop generated as the bedside monitor was turned off.16:03:54, the patient conflict was resolved.16:04:16, bedside monitor was turn on.16:04:29, the patient data was update at the bedside monitor.16:05:13 spo2 low generated.16:05:48 desat alarm generated on the device xprt6se04.The sector display of the spo2 value is 74.16:05:52, alarm acknowledged at device xprt6se04 16:07:00 desat alarm ended.16:07:20 spo2 low generated.The (pic ix) sector entry in the spo2 value of 87 16:07:33 spo2 low ended.16:12:62, device was off line and a no data monitor inop generated at the pic ix.16:12:50, patient transferred to 8ne11.The monitor has the alarm text configured enhanced because the alarms appear as spo2 81 < 90.The xprt6se04 has the alarm text configured standard because the alarms appear as spo2 low.And when the alarm appears at the pic ix, the data is listed as spo2 (spo2 = 87).According to the audit logs (both 6se and 8ne) spo2 low and desat alarms were generated.A desat alarm was generated at 16:05, for a value of 74.When you take a monitor out of standby or turn on, all alarms are paused for one minute.This is to allow for time to connect the patient to the monitor without alarms.The criteria for announcing a spo2 desat alarm is 20 seconds below the desat alarm setting.The alarm sounded at 16:05:48 on 6se16 and ended at 16:07.The monitor alarms resumed on 8ne11 at 16:14:07.At 16:15:08, a spo2 83 <90 was generated on 8ne11.Based on the information available the reported problem was not confirmed.An analysis of the provided information was performed and a investigation has been completed.Based on the configuration settings of the device, 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: 18710156
• MDR Text Key: 336525725
• Report Number: 9610816-2024-00078
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• 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