MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PHILIPS INTELLIVUE MP5 PATIENT MONITOR

Catalog Number RQPH2105- NSET

Device Problems Circuit Failure (1089); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Visual inspection was performed and identified that the mp5 tag was missing.Technical evaluation was performed which confirmed the reported issue of there being no power on the recorder.The technician replaced the recorder board with a refurbished one, checked for case damage, inspected the circuit board, checked that the options were set to h10 a04 c00 c01 c15 c20, set the soft to m.04.00, and tested the device on a simulator.The display test, ecg test, network lan/wlan check, nibp test, on/off power test, recorder test, temperature test, and final visual inspection all passed.Based on the reported event and the device evaluation analysis the root cause was determined to be a recorder board failure due to aged parts.No further investigation is required.This type of event will continue to be monitored.

Event Description

Reportedly, post purchase, there was no power to the recorder.There was no report of patient involvement.

• Brand Name: PHILIPS INTELLIVUE MP5 PATIENT MONITOR
• Type of Device: MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.; hewlett-packard-str. 2; D-710 34; GM D-71034
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 8908274
• MDR Text Key: 167647786
• Report Number: 3007409280-2019-00005
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/29/2019

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 Catalogue Number: RQPH2105- NSET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/19/2019
• 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