MAUDE Adverse Event Report: HUNTLEIGH HEALTHCARE LTD SONICAID; FM830 ADAPT

Model Number FM830

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Misdiagnosis (2159); Injury (2348)

Event Date 11/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report on findings: with knowledge of the design it is determined that noise could have been generated by the faulty tdr and as a result the meter/display could have produced a "flat line" trace.Although, without certain evidence and facts, this report cannot conclude with a root cause.What is meant by "flat line" is that we would not expect this to be a ruler-straight line, but an intermittent line with a level of dropout and a level of noise superimposed.We would also expect this to reflect in audible interference which would clearly sound abnormal & we would not expect this to be readily mistaken for true physiological sounds.We cannot comment further as to the clinical situation & the decision to perform a caesarean section without seeing the trace concerned & further information than has been supplied, concerning the clinical scenario - eg.Gestational age, clinical history, indications for monitoring, whether the mother was in labour or not, the length of the trace on which the clinical decision was made, any previous traces, what other tests were performed, etc.According to our service database this monitor was sold 02/08/2001 making it 15 years old.This unit was returned to huntleigh for repair once in october 2008 with a damaged spo2 cable assembly and not related to this incident.It is also confirmed that there is no maintenance programme in place for the hospital in question.No other service reports have been logged for the unit in question.(b)(4).Review of traces: no traces were presented.Conclusion: with the limited information available (unit not manufactured by huntleigh (b)(4)) and the age of the unit in question, no accurate confirmation can be made as to the root cause of the decision to conduct a c-section.What is clear though is that the clinical protocol (refer to alternative methods prior to taking medical action) has not been followed.Risk assessment: with the information provided the risk management file has been reviewed and concluded that the mitigation of the associated risks 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 & individual clinician's practices.While appropriate messages are available to the user (ifu and trace), there is a likelihood of recurrence of these sorts of incidents if these messages are not acted on appropriately and if other clinical signs are ignored.No similar issue has been reported.Corrective / preventative actions, including field safety corrective actions: none required.

Event Description

Heart rate reading about 110bpm.There was interference causing the meter to give an abnormal reading.Incorrect fetal heart rate informed wrong diagnosis leading to an unnecessary caesarean section procedure.Baby and mother were healthy post operation.The fault of the interference was found with the yellow 1.5mhz ultrasound transducer which had a non visable cable break causing a lot of interference to be picked up.

• Brand Name: SONICAID
• Type of Device: FM830 ADAPT
• Manufacturer (Section D): HUNTLEIGH HEALTHCARE LTD; 35 portmanmoor road; cardiff, south glamorgan CF24 5HN; UK CF24 5HN
• Manufacturer (Section G): HUNTLEIGH HEALTHCARE LTD; 35 portmanmoor road; cardiff, south glamorgan CF24 5HN; UK CF24 5HN
• Manufacturer Contact: pamela wright ; 12625 wetmore rd; site 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 5441339
• MDR Text Key: 38410534
• Report Number: 1000589001-2016-00001
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FM830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2016
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2016
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Disability