MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240

Device Problem Protective Measures Problem (3015)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

The audit logs were reviewed by the product safety engineer (pse) and states the following results - in the audit log, there was a yellow alarm generated for that non-sustain vt at 10:51:26.And then there was an acknowledgement on the bsicusurv at 10:51:37.It was not long only 11 seconds.But it does show that the alarm did occur and someone acknowledged it.Pse confirmed device was operating per specifications and no malfunction was identified.Based on the information provided in the case, pse evaluated the device logs provided by the customer and it was confirmed to be operating per specifications.Yellow alarms occurred and acknowledged.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

The customer reported that while standing at the pic and looking at a different patient's sector, she looked over and looked at this patient's sector and noticed there was a non-sustained vtach occurring, but there was no alarm banner and the sector did not alert her.No patient harm was reported.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 PATIENT MONITOR
• 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: 19168457
• MDR Text Key: 341432689
• Report Number: 9610816-2024-00223
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• 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

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: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2018
• 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