Recall Z-1167-2020

Reason for recall

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

FDA-determined cause: Device Design

Action taken

On 09/11/19, gent Medical Device Recall notices were emailed to customers. Customers were advised of the following possible failures associated with the post-market events: 1) Fluid damage/intrusion, solder cracks, component failure, 2) Damaged membrane or cracked case, 3) Internal short from usage, broken connector from misuse, 4) Broken leads, loose coil, 5) Loose crystal from failure of adhesive, internal short or improper grounding, 6) Miscalibration of the device/waveform, 7) Overheat of device. Malfunction of the device is likely to be recognized easily because the device will not function properly without intact components. If wave forms are not capturing the clinical data including fetal heart rate, oxygen saturation, patient's temperature or uterine activity, the device should not be used. Immediate actions to be taken by the Customer/User: - Inspect the device before each use to observe for any signs of device damage including cracked case, broken leads, loose coils, or damaged components and immediately remove the device from clinical service. - If any fluid intrusion is noted, remove the device from service immediately. - Any signs that the device is overheating should be recognized as a potential serious issue and should not be used and/or removed from the patient immediately. - If waveforms are not capturing on the monitor or there is artifact, this may be due to miscalibration of the device or a component malfunction. Remove the device from service. If there are no signs of product damage or deterioration, the serviced devices may continue to be used with continued monitoring of device performance. Maintain this notification at your facility and review the content of this letter with your staff. Complete and return the customer acknowledgement form to the recalling firm. If you have subsequently resold or distributed the affected product, please ensure that this information is provided to your customer(s). Customers with additio