Heartstart XL, Heartstart MRX Defibrillator/Monitor and Heartstart XL+ (2018-04-18)

Starting date:

April 18, 2018

Posting date:

May 18, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66814

• 
  Reason
• 
  Affected products

Affected products

A. Heartstart XL

B. HEARTSTART MRX Defibrillator/Monitor

C. HEARTSTART XL+

Reason

When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from

electrical fast transients (EFTs):

- On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave.

- On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*.

*Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: "When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+." If the user follows this warning, this problem cannot occur on the XL+.

Affected products