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

Model Number PWCD-B

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/07/2023

Event Type  malfunction  

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.Hillrom requested the damaged power cord to be returned for inspection, however the part has not been received.The customer was provided with a new power cord to resolve the issue.Based on this information no further actions are required at this time.Although there was no reported injury with this event, if the report of a torn power cords with exposed wires were to recur, it could potentially cause serious injury or death.Therefore hillrom is reporting this event.

Event Description

Customer reported the power cord was torn.There was no allegation of injury report.This incident was captured under hillrom complaint ref #(b)(4).

• Brand Name: LINE CORD B, NORTH AMERICA
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH 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: 17247919
• MDR Text Key: 318355849
• Report Number: 1316463-2023-00150
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2023

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-B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/03/2023
• 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