MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD VERIS MR VITAL SIGNS MONITOR; MONITOR, PHYSIOLOGICAL PATIENT

Model Number 59350459

Device Problem Unintended Electrical Shock (4018)

Patient Problem Burn(s) (1757)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.

Event Description

The customer reported the following: upon unplugging the veris mr vital signs monitor, the technologist immediately felt a shock sensation to his hand.He was evaluated in the emergency department at which time he was confirmed to have sustained burns to three of his fingers.There is no other information available as to the employee's current condition.

Manufacturer Narrative

A bayer service representative visited the site and replaced the power cable, power cord set, power supply and o2 sensor and the system was returned to normal operation.Product analysis received and examined the returned components.Visual inspection of the power cable confirmed that the cable had melted, and several areas showed exposed wiring.The lemo connector was removed and several of the wires showed thermal degradation of their insulation, leading to exposed conductors.Product analysis determined the cause of the reported issue was damage to the lemo connector wiring which led to a short circuit condition and, subsequently, the melting of the cables and reported electrical shock.On april 15, 2013 bayer healthcare distributed a field safety notice recalling all 25-foot dc power cables shipped with medrad veris mr vital signs monitors, or those provided by bayer service.Those power cables were recalled due to a latent design reliability issue and the potential for shorting which could result in heating/melting of the cable jacket.Product analysis reviewed the system serial number and determined that the system was subject to this recall and the power cable should have been returned.Bayer records confirmed that an urgent medical device component recall form and letter was sent to the customer on three separate occasions, none of which were acknowledged and returned.The site continued to use the affected cable until the time of the reported event.

• Brand Name: MEDRAD VERIS MR VITAL SIGNS MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL PATIENT
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 9364577
• MDR Text Key: 168181007
• Report Number: 2520313-2019-00056
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K042569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 59350459
• Device Catalogue Number: VERIS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1586-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Other