MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP20

Model Number 862134

Device Problem Erratic Results (4059)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

The customer reported that the patient was sent to the emergency department for rescue due to "cardiopulmonary arrest for 20 minutes" from 120, and electrocardiogram monitoring was given according to the doctor's advice.After cardiopulmonary resuscitation for more than 10 minutes, the patient recovered his autonomous heart rate, and the ecg waveform of the electrocardiogram monitor did not show.The ecg waveform still showed a straight line, which was not consistent with the reality.Replace the ecg monitor immediately and ask the maintenance personnel of the equipment department for maintenance.

Manufacturer Narrative

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

Manufacturer Narrative

A philips post market surveillance manager (pmsm) remotely interviewed the customer and confirmed there was no issues with the 5 lead ecg electrodes, and they were purchased from philips.The root cause of the issue was determined to be the parameter board.Once the parameter board was replaced, the unit was returned to user specification.After parameter board replacement the device was returned to functional use with no further issues identified.The device remains at the customer site.

• Brand Name: INTELLIVUE MP20
• Type of Device: INTELLIVUE MP20
• 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: 17321702
• MDR Text Key: 319346283
• Report Number: 9610816-2023-00351
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122439
• 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: 862134
• Device Catalogue Number: 862134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/24/2023
• Date Device Manufactured: 09/19/2014
• 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