IACS Monitoring Solution with C500 and C700, and Infinity M540 (2018-02-28)
- Starting date:
- February 28, 2018
- Posting date:
- May 25, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66880
Affected products
- IACS Monitoring Solution with C500
- IACS Monitoring Solution with C700
- Infinity M540
Reason
When the Infinity M540 patient monitor is placed in standby mode and the user simultaneously connects the Infinity MCable - Dual Hemo or Infinity MPod – Quad Hemo to the Infinity M540 patient monitor and then proceeds to zero the invasive pressure channel, in rare cases the invasive pressure visual and audible alarms are not activated. Although the invasive pressure value displayed on the Infinity M540 patient monitor and on the infinity medical cockpit is accurate, the invasive pressure visual and audible alarms will stay disabled until the patient is discharged or the hemodynamic pod is disconnected and reconnected.
Affected products
A. IACS Monitoring Solution with C500
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MS25510
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
UNITED STATES
B. IACS Monitoring Solution with C700
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MS25520
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
UNITED STATES
C. Infinity M540
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MS20401
MS22956
MS25643
MS26196
MS31818
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
UNITED STATES