MAUDE Adverse Event Report: WELCH ALLYN, INC. VSM6400/SPN/PR/PLUG2; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number 64NXPX-2

Device Problems Flare or Flash (2942); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

The connex vsm 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for noninvasive blood pressure (nibp), pulse rate (pr), noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), body temperature in normal and axillary modes.The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.Monitoring can be accomplished on the vsm 6000 series bedside monitor itself, and the vsm 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.G., at a central station).Secondary remote viewing and alarming features are intended to supplement and not replace any patient bedside monitoring procedures.No further information is available on the device at this time.The device is currently on route to our european service center where it will be preliminarily inspected.The device will then been forwarded to the hillrom manufacturer in (b)(6) for a thorough investigation.Hillrom will submit a final report with investigation conclusion on this incident.

Event Description

Customer reported that while the connex vsm 6000 device was connected to mains power, during power-on of the device a flame burst came out of the device's blood pressure measurement device and a caregiver experienced an electrical shock.It was also reported that the caregiver was not injured and was able to continue her work without any treatment.

Manufacturer Narrative

The connex vsm 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for noninvasive blood pressure (nibp), pulse rate (pr), noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), body temperature in normal and axillary modes.The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.Monitoring can be accomplished on the vsm 6000 series bedside monitor itself, and the vsm 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.G., at a central station).Secondary remote viewing and alarming features are intended to supplement and not replace any patient bedside monitoring procedures.No further information is available on the device at this time.The device is currently on route to our european service center where it will be preliminarily inspected.The device will then been forwarded to the hillrom manufacturer in (b)(4) for a thorough investigation.Hillrom will submit a final report with investigation conclusion on this incident.

Event Description

Customer reported that while the connex vsm 6000 device was connected to mains power, during power-on of the device a flame burst came out of the device's blood pressure measurement device and a caregiver experienced an electrical shock.It was also reported that the caregiver was not injured and was able to continue her work without any treatment.

Manufacturer Narrative

The connex vsm 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for: noninvasive blood pressure (nibp); pulse rate (pr); noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2); body temperature in normal and axillary modes.The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.Monitoring can be accomplished on the vsm 6000 series bedside monitor itself, and the vsm 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.G., at a central station).Secondary remote viewing and alarming features are intended to supplement and not replace any patient bedside monitoring procedures.All welch allyn electrical devices are designed and tested to meet all applicable safety and flammability regulations.Welch allyn's vital signs, cardio and monitoring electrical devices are not held by the user and therefore decrease the likelihood that the user would sustain a 1st or 2nd degree burn if the device were to become hot.If these burns were to occur, they would generally not be considered serious and would heal without further medical intervention.All electrically powered welch allyn medical devices are designed, validated & manufactured per the isolation standards in "1ec 60601-1 as applicable.The standard is referenced in the device directions for use.This assures that the mains power is isolated after the transformer to prevent injury to the patient and user form the mains electrical power.Electric shock occurs upon contact of a (human) body part with any source of electricity that causes a sufficient current through the skin, muscles, or hair.An electric shock may or may not result in injury.Shock injury is relative to the magnitude of current the body is exposed to, individual body impedance, and area of exposure.Additionally, if a device were to get hot to touch, spark, have burn marks or burned components a trained clinician would not use the device and remove it from the patient's environment.Device investigation showed that the power supply failed and was the cause of the flame burst.The fuses blown on the power supply indicate that the failure originated on the ac side of the transformers.In conclusion, although the reported event did not result in a serious injury, the report of flame bursting from the power supply during use could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

Event Description

Customer reported that while the connex vsm 6000 device was connected to mains power, during power-on of the device a flame burst came out of the device's blood pressure measurement device and a caregiver experienced an electrical shock.It was also reported that the caregiver was not injured and was able to continue her work without any treatment.The power supply was received at hillrom service centre where it was preliminarily inspected.The preliminary investigation shows that the power supply failed and was the cause of the flame burst.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: VSM6400/SPN/PR/PLUG2
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13583363
• MDR Text Key: 285980855
• Report Number: 1316463-2022-00012
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00732094090765
• UDI-Public: 732094090765
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

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 Model Number: 64NXPX-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 02/10/2022
• Supplement Dates FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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