MAUDE Adverse Event Report: WELCH ALLYN CONNEX SPOT 35 WATT POWER SUPPLY; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number 7000-PS

Device Problem Arcing (2583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

The customer reported that the csm power supply was arcing and making a cracking sound when the mains lead was plugged in.This event was captured under hillrom complaint ref #: (b)(4).

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 7000-ps is the connex spot monitor 35 watt power supply.For protection against shock, electrically powered welch allyn medical devices are designed, validated and manufactured per the isolation standards in "iec 60601-1".The standard is referenced in the instructions for use.This assures that the mains power is isolated to prevent injury to the patient and user from the mains electrical power.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.As the device was not returned by the customer, therefore a thorough investigation into the reported malfunction could not be performed.If the device is returned, hillrom will conduct a thorough device analysis and forward any findings in a supplemental report.Although the reported event did not result in a serious injury, the report of arcing of the device's power supply could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

• Brand Name: CONNEX SPOT 35 WATT POWER SUPPLY
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15948987
• MDR Text Key: 306286588
• Report Number: 1316463-2022-00166
• Device Sequence Number: 1
• Product Code: MWI
• UDI-Device Identifier: 00732094212976
• UDI-Public: 732094212976
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7000-PS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1