MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC UNK-0238 TELE

Catalog Number UNK283-TELE

Device Problem Alarm Not Visible (1022)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 11/17/2022

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported after a code blue a patient died.Looking back through the patient data after they noticed ecg changes.The customer has st monitoring on and alarms off.Ste monitoring is also on with alarms on as well.After reviewing strips they reported there was st elevation, and there were many pvc alarms throughout the day but no ste alarms.The customer reported the possibility of ste alarms not generating 11/30, and the audit log would be investigated.Audit log was reviewed on 12/5 after customer reported this patient had died.

• Brand Name: UNK-0238 TELE
• Type of Device: UNK-0238 TELE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16012069
• MDR Text Key: 306776792
• Report Number: 1218950-2022-01062
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: UNK283-TELE
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/20/2022
• 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): Death
• Patient Sex: Female