Samaritan PAD SAM 300 and 300P

Starting date:

October 2, 2012

Posting date:

October 15, 2012

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-15148

• Reason
• Affected products

Recalled Products:

1. Samaritan PAD SAM 300
2. Samaritan PAD SAM 300P

Reason

Devices within these serial number ranges may be affected by one of both of these 2 identified issues :

Issue one: devices may intermittently, or sometimes repeatedly, switch themselves on, and remain on for 10 minutes, which could eventually cause premature depletion of battery capacity. Should this condition not be detected the battery may become depleted below a level where it could power the device to safely deliver therapy if required.

Issue two: the battery management software in affected devices may misinterpret changes in voltage which occur during the normal operation of the device, as indications of a low battery capacity. This can trigger an unnecessary low battery warning which, if it occurs during an rescue event may cause the device to switch off and/or may delay the delivery of shock therapy. Further information can be found at www.heartsine.com/recall

Affected products