MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOREST MODEL (IV) ETHOS; IKZ

Model Number 8259965

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Electric Shock (2554); No Patient Involvement (2645)

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was an actual technical malfunction of the device (we found no evidence of it), but since the information received could be interpreted as the device not having performed as intended.When reviewing similar reportable events for the rotorest bed, we have not been able to find any fault with the similar fault descriptions compared to the situation investigated here: electrical shock.There is no trend observed for reportable complaints with this failure for rotorest bed.Based on the information collected to date, the provided problem description and the inspection of the device, it would appear that the rotorest was not the source of the electrical discharge that has been alleged by the facility.The device involved in the event was inspected by an arjohuntleigh representative who managed to establish that all the device's functions were working correctly.The device also passed the electrical safety test - the earth resistance was equal to 0,187 ohm, the earth leakage current was less than 0,5ma.Also the service history of the device was reviewed and it has not shown any events similar to the one investigated here.Additional information revealed by the facility, indicate that the electric shock was received when the bed (with no patient inside) was about to be moved through an automatic door.The bed was not plugged into the mains at that time.The nurse pushed the automatic door opener by her hand, with the other hand she touched the bed to push it through the door.In that very moment when the door opener was touched, she received the electrical shock.From her "feeling" she thinks, that the electric shock came from the door openers direction.In summary, the device has not failed to meet its specification, was being in use at the time of event - transit of the bed (without patient) within a hospital, and due to this played a role in the incident.Fortunately, the caregiver has not suffered serious injury.Information provided by the facility and conducted evaluation lead to the conclusion that the rotorest device was not the source of the claimed electrical discharge.Nevertheless, we have decided to report this based on the initial information that the electrical shock occurred and in the abundance of caution.Given the circumstances and the fact that this incident appears to be a remote one, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Initially, it has been claimed by the facility that the nurse got an electrical shock by touching the bed, while transiting it within the hospital.No patient was involved and the bed was not connected to the mains.The nurse who received the electrical shock, visited the doctor after the event - no serious injury was diagnosed.The next day, nurse went back to work.

• Brand Name: ROTOREST MODEL (IV) ETHOS
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5242091
• MDR Text Key: 31788053
• Report Number: 3007420694-2015-00216
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: LU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/23/2015,10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 8259965
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2015
• Distributor Facility Aware Date: 10/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2015
• 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
• Patient Outcome(s): Other