MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS MX40 WITH PIIC IX; DETECTOR AND ALARM, ARRHYTHMIA

Model Number MX40 SOFTWARE B.06.51

Device Problem Battery Problem (2885)

Patient Problem Death (1802)

Event Date 12/06/2018

Event Type  Death  

Event Description

Philips monitor battery died, pt coded at approx 1750.The monitor shows that it stopped monitoring at 1725.The code was started at 550 and continued for 30 min.The pt was found to have a pulse and was transferred to icu.Equipment software version model mx 40 b.06.51, piic ix b.02.15 m3290b.

• Brand Name: PHILIPS MX40 WITH PIIC IX
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS
• MDR Report Key: 8189429
• MDR Text Key: 131308298
• Report Number: MW5082380
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: MX40 SOFTWARE B.06.51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 91