MAUDE Adverse Event Report: WELCH ALLYN, INC. LINE CORD 2, EUROPE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number PWCD-2

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 06/03/2022

Event Type  malfunction  

Event Description

The customer reported that the pins of the cvsm power cable are blackened.It was also reported that this has happened with multiple cvsm devices and that these devices are still working correctly.There was no report of sparks or flames observed by the staff.This report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

Hillrom is in the process of contacting the customer for additional information.The components involved in this event will be returned to the manufacturing site for a further investigation.Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.

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.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.To prevent injury from exposed wires and damaged housing, there are warnings in the dfu including: cords, cables, and accessories damaged from prior misuse can affect patient and operator safety.Inspect all cords, cables, and accessories for strain relief wear, fraying, or other damage according to the recommendations presented in the maintenance and service section of this manual.Replace as necessary.Inspect the ac cord for exposed copper before touching the cord.Unplug the ac cord only by pulling on the plug, never the cord.Never lift the monitor by the power cord or patient connections.If the instruction as outlined above are followed it is very unlikely for an injury to occur due to a similar event.The power cords were returned to the manufacturer for further investigations.Initial observation of five cables shows that all cables have some black discoloration on the mains entry power cord pins.The connectors of the five cables also have some black discoloration and use marks on them.The tip of the circular pin is slightly deformed which might be due to the sparks occurred when the device was plugged into mains input and/or the friction between the connections.Previous investigations on similar events have shown that increased pitting and wear on the tip of the power plug pin over time can eventually lead to a looser connection between the power plug and the internal outlet contacts, which can cause the electrical sparking happened in this case.Also, once power cord pins are bent, they can cause damage and wear to the outlet contacts.That could also lead to a looser connection between the power plug and the internal outlet contacts.Therefore, the poor condition of the power plug prongs, bad ac outlet pins, bad electrical wiring in the outlet, or another problem with the ac outlet have been previously seen to cause these issues.The electrical sparking condition may not occur every time a device is plugged in, but can occur intermittently as a result of these conditions and is likely to be the root cause of these ¿sparking¿ complaints.Although the reported event did not result in a serious injury, the report of a spark of the device's power cable could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

Event Description

The customer reported that the pins of the cvsm power cable are blackened.It was also reported that this has happened with multiple cvsm devices and that these devices are still working correctly.There was no report of sparks or flames observed by the staff.This report was filed in our complaint handling system as (b)(4).

• Brand Name: LINE CORD 2, EUROPE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14873516
• MDR Text Key: 295067661
• Report Number: 1316463-2022-00100
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00732094090673
• UDI-Public: 732094090673
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

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: PWCD-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 08/12/2022
• 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