Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
Recall
- Recall Number
- Z-0534-05
- Event Number
- 30811
- Firm
- Smiths Medical PM, Inc.
- FEI Number
- 2183502
- Product Code
- DPS
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 5, 2005
- Posted
- February 10, 2005
- Terminated
- November 14, 2005
- Address
- N7w22025 Johnson Dr, Waukesha, WI, 53186-1856
Description
Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading.
On 12/22/04 distribution of new units was placed on hold and customers were notified to recommend that they do not use the pace detect function. On 12/27/03 an email was sent to customers of the solution. On 12/29/04 a Technical Worksheet describing how to replace a resistor at R8 was emailed to customers. Between 12/29/04 and 01/03/05 kits containing instructions and new resistors were sent to customers to begin reworking of the devices.
Internationally only.
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