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 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the device at this time.The device is being returned to the hillrom manufacturer for a thorough investigation.Hillrom will submit a final report with investigation conclusion on this incident.

Event Description

Customer reported the power cord was damaged with exposed wires.There was no allegation of injury report.This incident was captured under hillrom complaint ref # (b)(6).

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 ¿ non-invasive 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.Pwcd-b is the part # of the power cord used with the cvsm device.The device was not returned by the customer, therefore a thorough investigation into the reported malfunction could not be performed.Hillrom has provided the customer with a new power cord.Although the reported event did not result in a serious injury, the report of a power cord with exposed wires could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

Event Description

Customer reported the power cord was damaged with exposed wires.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: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17584518
• MDR Text Key: 321542881
• Report Number: 1316463-2023-00186
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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