IACS MONITORING SOLUTION WITH C500, C700 & INFINITY M540 (2020-12-30)
- Starting date:
- December 30, 2020
- Posting date:
- January 22, 2021
- 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-74821
Last updated:
2021-01-22
Affected Products
- IACS MONITORING SOLUTION WITH C500
- IACS MONITORING SOLUTION WITH C700
- INFINITY M540
Reason
The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.
Affected products
A. IACS MONITORING SOLUTION WITH C500
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
MS25510
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES
B. IACS MONITORING SOLUTION WITH C700
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
MS25520
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES
C. INFINITY M540
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
MS20401
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES