MAUDE Adverse Event Report: WELCH ALLYN INC. WIFI CSM,NIBP,COVIDIEN, SURETEMP,PLUG4; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number 75CT-4

Device Problems Fire (1245); Smoking (1585)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The connex spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), respiration rate, and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments.This product is available for sale only upon the order of a physician or licensed health care professional.The csm has been returned and a preliminary investigation has been performed.When the device housing was removed and the device was examined internally, a minor burn mark to an internal component was identified when viewed under the lens.In order to determine the root cause of the fire, hillrom would need to investigate further the power supply and cable used by the customer.The power supply and accessories have not been returned by the customer at this point.Hillrom is attempting to obtain the power cables and accessories from the customer.No further information is available at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Welch allyn received a report from the account stating the csm device caught fire.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Event Description

Welch allyn received a report from the account stating the csm device caught fire.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The customer reported that a strong burning smell came from the unit and visible smoke after plugging the csm to a power supply.The connex spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), respiration rate, and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments.The csm has been returned and a preliminary investigation has been performed.When the device housing was removed and the device was examined internally, a minor burn mark to an internal component was identified when viewed under the lens.Hillrom has attempted several times to get the power supply returned to perform a full investigation but the customer was unresponsive.Based on information provided and device returned, a limited investigation was concluded.The root cause of the failure has been identified, as follows: no protections in the design while input power connector being plugged in 180 degree off.Limitations in the design to protect the the internal parts from transient voltage occurrences.An updated design was qualified to fix all the above issues listed as root causes based on the similar field complaints in december 2018.The new pcba is (b)(4).Currently manufactured csm device uses updated pcba (b)(4).Protection circuits, tvs diodes and other design changes are included to improve the robustness of the csm device.A review of the risk analysis shows that risk of harm due to pcba electronic components experiencing overheating/shorting out due to reverse power or a surge is negligible as the pcb (printed circuit board) on which this component mounted meets the flammability rating of ul94 v-0.As per the investigation, a minor burn mark to an internal component was identified when reviewed under the lens.This would not result in an external overheating that could cause burn if touched.Should a biomed be servicing the device at the time the failure occurs, the duration of user skin contact is not likely to be long enough to cause a third degree burn since user is likely to immediately drop whatever they are handling that becomes harmful.Once the pcba's short circuit occurs, it is identified that the device becomes unavailable for use.Vitals signs are often obtained by clinicians in order to assess the most basic body functions.They include blood pressure, pulse, respiration and body temperature.Vital signs generally provide a reference for the clinician.If a welch allyn multi-parameter vital signs device were unavailable prior to use on a patient either during a spot vital sign check or at start-up of the monitoring mode, a trained clinician would implement their clinical skills and judgment to assess the patient's basic body functions.Vital signs can be assessed by other means such as observation and or auscultation and touch.If the device was to become unavailable for use while monitoring an unattended patient, the clinician would identify the issue when checking on the patient.When caring for unattended patients who are having their vital signs intermittently or continuously monitored, it is general clinical practice to visually monitor these patients more frequently.The patient's bedside monitor accurately reflects the patient's vital signs and would bring the clinician to the patient for any change in condition via alarms and alerts.Alternatively, the clinician may obtain an alternative device.Obtaining a backup device may result in a delay.Such delays are brief and would not result in significant risk to the patient.If a back-up device was unavailable, the patient could be rescheduled or referred to another practice.The trained clinician has many options and alternative ways of obtaining and assessing the patient's vital signs.Therefore, the unavailability of a vital signs device at start-up or intermittent/continuous monitoring causing a serious injury or death is negligible.There was no serious incident reported and should this malfunction recur, it is unlikely to cause or contribute to a serious incident for the reasons stated above.Therefore, hillrom does not consider this complaint reportable.

• Brand Name: WIFI CSM,NIBP,COVIDIEN, SURETEMP,PLUG4
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles falls NY 13153
• MDR Report Key: 11086900
• MDR Text Key: 224033654
• Report Number: 1316463-2020-00015
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00732094209532
• UDI-Public: 732094209532
• Combination Product (y/n): N
• PMA/PMN Number: K142356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 75CT-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1