MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX550 PATIENT MONITOR

Model Number INTELLIVUE MX550 PATIENT MONITOR

Device Problems Low Readings (2460); Insufficient Information (3190)

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

Event Date 10/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported incorrect monitoring results found during an operation, delaying treatment time.At 16:07 in the afternoon, the vital signs of patients were detected after coronary stent implantation.At 16:21, the equipment gave an alarm and found that the blood pressure and heartbeat were too low.The nurses found that the heartbeat was normal through manual measurement.After resetting the monitor, the detection was still inaccurate.The device was in clinical use a the time the issue was discovered.The reporter claimed potential injury of patient.

Event Description

The customer reported incorrect monitoring results found during an operation, delaying treatment time.At 16:07 in the afternoon, the vital signs of patients were detected after coronary stent implantation.At 16:21, the equipment gave an alarm and found that the blood pressure and heartbeat were too low.The nurses found that the heartbeat was normal through manual measurement.After resetting the monitor, the detection was still inaccurate.The device was in clinical use a the time the issue was discovered.The reporter claimed potential injury of patient.The report was sent for technical investigation.The reported problem was not confirmed; the reported problem was unable to be reproduced.After replacing the ecg electrodes and blood pressure cuffs, the equipment returned to perform measurements normally.The investigation confirmed there was no harm to the patient; at the time of the reported event, the nurses verified that the heartbeat was normal through manual measurement.No further information was provided.

• Brand Name: INTELLIVUE MX550 PATIENT MONITOR
• Type of Device: INTELLIVUE MX550 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15710035
• MDR Text Key: 302794283
• Report Number: 9610816-2022-00544
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: 00884838038783
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• 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: INTELLIVUE MX550 PATIENT MONITOR
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other