MAUDE Adverse Event Report: HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS SONICAID

Model Number FM830ENCORE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death, Intrauterine Fetal (1855)

Event Date 08/29/2014

Event Type  Death  

Event Description

The monitor was recording traces for an intra uterine fetal death.

Manufacturer Narrative

Arjohuntleigh, inc is submitting the report on behalf of huntleigh healthcare ltd.Exemption no.(b)(4).Having reviewed the limited information provided (pdf of trace provided dated (b)(6) 2014), the following points summarise the investigation: this would appear to have been a known high risk pregnancy, as indicated by the "g12p0" or more likely "g2p0" annotation (difficult to read) whether it's g12 or g2 it indicates that at least one, and possibly as many as 11, previous pregnancy(s) failed for some reason, making this pregnancy a high risk one by default.We would expect a high risk pregnancy to be more closely managed than a low risk pregnancy and for the user to be more alert to any possible problems a well-known, and well documented, limitation of all fetal monitors is that, in the absence of a fetal heart signal, the monitor can pick up on a maternal signal.Best practice, as specified in a number of national safety notices on this subject is to always check the maternal heart rate (pulse) at the start of the trace and record this on the trace.This should be repeated at regular intervals throughout the trace, ensuring that the maternal rate is different from the printed fhr trace and will alert users to the possibility that the fetus may be dead.It is also recommended that a pinard or fetal doppler is used before starting a trace to confirm fetal life and position.As a back-up to this best practice, use of the spo2 sensor (or bp or mecg) will allow the trace to print the maternal heart rate on the same scale as the fetal heart rate trace, making it very obvious if they are the same.It is noted from the trace print out that the spo2 sensor was actually plugged into the monitor during this trace but the absence of either spo2 values or maternal heart rate suggests that it was not actually applied to the patient.If this sensor had been used, the monitor would have alerted the user to the rates being the same.Before the start of the trace, there are a number of hand written annotations on the trace.One is "bp 116/72", clearly the maternal blood pressure.Below this is an annotation which cannot be read clearly.It is probable that, in line with the above stated best practice, they did check the maternal rate and this was recorded as 92bpm.This being the case, this is within the range of the recorded fetal heart rate trace and could have alerted the clinician to the trace being maternal in origin.There is nothing in this trace to indicate that there is any fault with the fetal monitor.The conclusion based on the limited information provided is that this fetus may have been dead before the trace was started and that the printed trace represents that of the mother.Use of the spo2 sensor would have made this both visually obvious and would have triggered the monitor's cross channel alert risk management file has been reviewed and concluded that the mitigation of the associated risks are appropriate, have been adequately documented and are acceptable, i.E., warnings have been included in relevant areas.However, we cannot state the problem will not reoccur as further mitigation of these risks is outside our direct control, being driven by local & national guidelines, protocols, training and individual clinician's practices.Similar issue has been reported and this was also concluded as above.Corrective i preventative actions, including field safety corrective actions - none required.

• Brand Name: SONICAID
• Manufacturer (Section D): HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS; 35 portmanmoor rd.; cardiff
• Manufacturer (Section G): HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS; 35 portmanmoor rd.; cardiff
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonia, TX 78247 ; 2102787040
• MDR Report Key: 4131195
• MDR Text Key: 15325882
• Report Number: 1000589001-2014-00004
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: MU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2014,09/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FM830ENCORE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2014
• Distributor Facility Aware Date: 09/01/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2014
• Date Manufacturer Received: 09/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death