MAUDE Adverse Event Report: WELCH ALLYN INC CONNEX SPOT ACCY POWER MGMT STAND; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	7000-APM
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned where an initial inspection confirmed the apms internal components had overheated, the device is pending a thorough investigation into the root case of the reported issue by the manufacturer.A supplementary report will be submitted upon completion of the investigation.
Event or Problem Description
Customer reported that a strong smell of burning was coming from the accessory power management (apm).The apm was unscrewed and it was found that an internal component has burned on the power supply board.There was no adverse event reported.
Additional Manufacturer Narrative
The apm was visually inspected internally and externally, and component / pcba damage was observed.The 7000-apm was electrically inspected to confirm the integrity of the primary input fuses, the primary to secondary isolation.Since no damage other than thermistor r10 was found, it was tested for functionality after bypassing the thermistor r10 with a jumper.The evidence indicated that thermistor r10 failed.In addition to r10 failing, significant heat was generated which damaged the bottom side of the circuit board beneath r10.The ac input fuses were still intact (not open/ not blown) and the primary to secondary isolation boundary had not been compromised.The investigation findings concluded the thermistor r10 failed due to an overvoltage / surge pulses above the specification limit of the mains input.Reports of thermal/electrical damage to an internal component do not represent a hazardous situation to the end user as the device is not intended to be held by the end user and therefore decreases the likelihood of severe injury or death to negligible.After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.
Event or Problem Description
Customer reported that a strong smell of burning was coming from the accessory power management (apm).The apm was unscrewed and it was found that an internal component has burned on the power supply board.There was no adverse event reported.

• Brand Name: CONNEX SPOT ACCY POWER MGMT STAND
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 21302445
• Report Number: 1316463-2025-00016
• Device Sequence Number: 12973897
• Product Code: MWI
• UDI-Device Identifier: 00732094210613
• UDI-Public: 732094210613
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 7000-APM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown