MAUDE Adverse Event Report: WELCH ALLYN INC CP150_INT,AHA,D,EN,AU_PCORD; ELECTROCARDIOGRAPH

Model Number	CP150A-1EN66
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up with the customer found that the caregiver grabbed the end of the lead (damaged/detached power mod) and attempted to plug the mod with an attached power cord into the device.Of note, the power cord was was plugged into a power point at the time, the customer reported the caregiver received the shock when attempting to plug it in.The cp 150 electrocardiography device is intended for use by trained operators in health facilities for diagnostic purposes in acquiring, viewing, storing, and printing ecg waveforms using ecg front-end modules (patient cables) and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ecg waveforms through surface electrodes adhered to the body.These are presented for review and interpretation by the clinician based upon knowledge of the patient, the result of physical examination, the ecg tracings, and other clinical findings.The device instructions for use instructs the user to inspect the equipment daily for the following: check for cracked or broken patient cable, patient electrodes, power cord, communications cables, display, and enclosure.The initial inspection of the device by the facility's maintenance representative found the device to have visible damage, noting that the device's iec 240v power mod was completely broken off with a 240v orange power cord still attached.The device was returned for repair where the hrc technician found the iec socket was totally broken off from the device with ac power cord attached.The iec socket side latch with housing was broken, the housing where the iec socket fit in on one side was chipped and all 3 power wires were completely disconnected from the iec socket.The technician determined that the most likely cause was by pulling the ecg when the power cable was still plugged into the wall socket, which broke the housing and the iec socket latch and pulled the whole iec socket out of the device without the wire connected leaving all pins exposed which caused the shock.In this event the caregiver was noted to have received a shock.Observation was performed the caregiver was noted to be well and returned to work, with no medical intervention required.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.Shock injury is relative to the magnitude of current the body is exposed to, individual body impedance, and area of exposure.The cause of the event is attributed to the caregiver touching the device's detached power mod while the mod was connected to a power supply.Although there was no serious injury with this reported event, if the report of shock associated with handling a damaged power mod were to recur while the device is connected to an ac power supply, the voltage transferred from the ac outlet is likely to cause or contribute to serious injury or death.
Event or Problem Description
It was reported that a caregiver received a shock due to a damaged power cord on the cp150 electrocardiograph device.No medical intervention was required, the caregiver was placed under observation and was noted to be well and returned to work.This incident was captured under (b)(4).

• Brand Name: CP150_INT,AHA,D,EN,AU_PCORD
• Common Device Name: ELECTROCARDIOGRAPH
• 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: 20426082
• Report Number: 1316463-2024-00129
• Device Sequence Number: 7589975
• Product Code: DPS
• UDI-Device Identifier: 00732094177633
• UDI-Public: 00732094177633
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 10/11/2024

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: CP150A-1EN66
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/11/2024
• 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