MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; ARRHYTHMIA DETECTOR AND ALARM (INCLUDING ST-SEGMENT MEASUREMENT AND ALARM)

Model Number 863310

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.There is no allegation that the need for a "patient rescue" is a result of the a malfunction of the device.Additional information has been sought to clarify the device involvement to the alleged complaint.

Event Description

The customer contacted the customer care solution center and alleged an electrical and heart rate failure on the complaint device and requested support.This event occurred during patient monitoring.It is alleged that the patient required "rescue" procedures.It is currently unknown what those measures were.

Manufacturer Narrative

H10: information was provided to the investigator which indicated that an authorized service provider (asp) engineer initially assisted the customer by video over the telephone.A non-philips engineer was dispatched to the customer facility to test and evaluate the complaint device.The asp engineer was unable to duplicate a failure of the complaint device to perform similar to the original problem description.The cause of the faulty electrical and heart rate measurement was unknown.The patient was saved after flat-lining during a "rescue process", however there is no allegation that the complaint device associated with this record was connected to the patient condition or flat-lining event.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Type of Device: ARRHYTHMIA DETECTOR AND ALARM (INCLUDING ST-SEGMENT MEASUREMENT AND ALARM)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9938013
• MDR Text Key: 187002418
• Report Number: 1218950-2020-02215
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K151812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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: 863310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1