MAUDE Adverse Event Report: WELCH ALLYN INC LINE CORD 4, U.K.; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number PWCD-4

Device Problem Overheating of Device (1437)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

On 29th jan 2024, hillrom received a user report stating the following customer complaint."moulding of 3 pin mains plug top cracking, strain relief breaks and internal lead connections breaking inside plug leading to arcing" there was no injury reported.This incident was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

The customer provided an image of the power cord which showed strain relief damage and cracking of the pug housing, there was also a burn mark indicating internal arcing of the plug.The power cord was not returned to hillrom for inspection, therefore a root cause of the reported issue could not be confirmed.The customer was provided with a replacement power cord to resolve the reported issue.The damaged power cord was scrapped.The welch allyn connex® integrated wall system combines the advanced, easy-to-use monitor capabilities of the welch allyn connex® vital signs monitor 6000 series with the welch allyn 767 power handles.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) nr ¿ 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.Although there was no injury reported, if the reported incident of arcing were to recur during use, it could lead to a serious injury of death, therefore hillrom is reporting this malfunction.

• Brand Name: LINE CORD 4, U.K.
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18767435
• MDR Text Key: 336111736
• Report Number: 1316463-2024-00034
• Device Sequence Number: 1
• Product Code: MHX
• 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: 02/23/2024

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: PWCD-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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