Cardiac Workstation
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Cardiac Workstation 5000 | Not applicable. | 860439 |
| Cardiac Workstation 7000 | Not applicable. | 860441 |
Issue
The cardiac workstation can intermittently provide inaccurate data related to the patient's native heart rate. Healthcare providers were able to recognize that secondary review was needed because the patient’s clinical presentation and symptoms were not consistent with the elevated heart rate displayed by the Cardiac Workstation. Although the elevated heart rate may serve as an indicator to the clinician that the data is inaccurate, the issue also impacts the accuracy of the entire ECG report, including waveform data, measurements, and interpretive statements. This issue is related to the Wired Patient Interface Module PIM accessory used with the Cardiac Workstation. In rare cases, when the Cardiac Workstation is returned from Standby mode, the system may not set the ECG sampling rate in the Wired PIM correctly. This can cause the ECG waveform and interpretation to be inaccurate.
Additional information
Details
Philips Medizin Systeme Boblingen Gmbh
Hewlett-Packard Strasse 2, Boblingen, Germany, 71034
Get notified
Receive emails about new and updated recall and safety alerts.