MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-30 for CENTURY AK63611-US manufactured by Arjo Hospital Equipment Ab.
[56551880]
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.
Patient Sequence No: 1, Text Type: D, B5
[61007982]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00205 |
| MDR Report Key | 5989697 |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-02 |
| Date of Event | 2014-09-01 |
| Date Facility Aware | 2016-09-02 |
| Report Date | 2016-10-28 |
| Date Reported to FDA | 2016-10-28 |
| Date Reported to Mfgr | 2016-10-28 |
| Date Mfgr Received | 2016-09-02 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2016-09-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURY |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-09-30 |
| Model Number | AK63611-US |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-30 |