MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problems Material Frayed (1262); Use of Device Problem (1670)

Patient Problems Concussion (2192); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a nurse was shocked due to a frayed cord on the cart.When she was shocked she was ¿knocked against the wall¿ which cause a concussion, shoulder problems, and 10 weeks of missed work.The power receptacle used was 220v.The facility was using one leg to provide 120v.The cords on the carts were not provided by the manufacturer.Osha has been notified.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Pma/510(k) number: k081047; k123188; k133786.No device history record review could be performed since no information about the device was provided by the customer while reporting the event and no other information was given during follow-up.No repair history review could be performed since no information about the device was provided by the customer while reporting the event and no other information was given during follow-up.On (b)(6) 2017, it was reported that the employees at a facility would be shocked by a frayed cord on a duo cart.Multiple attempts were made to contact the customer about the cart for additional clarification, but the customer was unable to provide any further information.It was noted on the product experience report form that a service technician evaluated the device and found that the cords on the carts were not provided by zimmer biomet or dornoch and that a 220v power source was used instead of a 120 v source to power the cart.Based on the information provided, a specific root cause of the frayed power cord shocking the customer was due to the customer using an incorrect power cord to attach the cart to an inappropriate power source.It was noted within the per form that the customer was using a power cord that was not provided by zimmer biomet or dornoch and that a 220v power source was used instead of a 120 v source to power the cart.The instructions for use for the ultra duo flex fluid cart (ultra cart instructions for use manual) states to use only dornoch approved accessories and to not attach items to the system that are not designed for use with the system and specifies that the cart is only supposed to be attached to a 115-120 v power supply.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6549630
• MDR Text Key: 74583842
• Report Number: 0001954182-2017-00005
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULDU500
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 01/15/2018
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other