MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB CENTURY; ILM

Model Number AK63611-US

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Headache (1880); Tingling (2171); Sweating (2444); Palpitations (2467); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

Arjohuntleigh received a customer complaint where it was reported that during a bath two years ago the resident was electrocuted.She let out a screech and continued with the bath.Few days after event the resident started to fell symptoms which were alleged to be the result of the shock.The symptoms were described as: tingling throughout the body, sense of imbalance, ringing in the ears, pain travelling up and down the spine, great pain in the knees and arms, constant headaches, speech difficulties, day and night sweats (hot and cold) and heart palpitations.There is no indication that any treatment was delivered as a result of this event.The facility was visited to gather more information and examine the device.There is no evidence or knowledge that an incident occurred, century tub is in excellent condition and correct working order.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for century we have found no other similar case where electrical shock occurred or was alleged, therefore we consider this case as isolated.It was alleged by the patient that during a bath session two years before, she felt electrical shock, what resulted in multiple symptoms, which allegedly became worse after time.The facility stated that there is no evidence or knowledge that any incident occurred.Arjohuntleigh's representative who performed device examination confirmed that the device was up to manufacturer's specification.A clinical expert, who was asked to assess severity of the harm, stated that it appears odd that the patient did not get a complete work up if she was actually shocked.The fact that she continued her bath and the nurse was not concerned also appears out of line with an actual electrical shock situation.Unfortunately, the arjohuntleigh representative who has been trying to contact the complainant in order to obtain more information from a medical professional who examined the person involved, or other relevant persons related to the event such as caregivers, without success.An assessment of what is being claimed could not be performed without any further evidence.In conclusion, no malfunction of the bath was found.It was used for patient's care and this way contributed to alleged event.Having that contradictory information we cannot confirm the event occurrence, establish exact scenario of events or root cause of the injuries.In case any additional information become available in the future, the investigation will be updated.

• Brand Name: CENTURY
• Type of Device: ILM
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5989697
• MDR Text Key: 56551880
• Report Number: 3007420694-2016-00205
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/28/2016,09/02/2016

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: Nurse
• Device Model Number: AK63611-US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2016
• Distributor Facility Aware Date: 09/02/2016
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/28/2016
• Initial Date Manufacturer Received: 09/02/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other