MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for TORNADO SP1000AR001 manufactured by Getinge Disinfection Ab.
[89238616]
(b)(4). From sep 2017 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[89238617]
On 2017-sep-11 arjohuntleigh was informed about the incident with regards to tornado flusher. In the received complaint, it was reported that open fire in the flusher was found. As a result of smoke development a smoke alarm has been triggered. The fire was extinguished with extinguishing foam and station was evacuated. There was no injury sustained. After the incident, the device was inspected by arjohuntleigh representative. Flusher was found in general good condition, although the function test failed. The device was under arjohuntleigh service contract. Last preventive maintenance was performed on july 2017.
Patient Sequence No: 1, Text Type: D, B5
[94552485]
(b)(4). An investigation was carried out into this complaint. On (b)(6) 2017 arjohuntleigh was informed about the incident involving tornado flusher. Following the information reported the open fire was found inside the flusher and a smoke development triggered activation of a smoke alarm in one of the customer facility rooms. The fire was extinguished with extinguishing foam and people from the customer facility were evacuated. There was no injury sustained in relation to this event. The photographic evidence provided within the complaint allowed us to establish that the electrical component plugged into the steam generator became damaged due to fire exposure. According to arjohuntleigh representative opinion, the fire was probably triggered by the plug connector on the steam generator. Further visual inspection revealed that the flusher was in general good condition except from the connector and the adjacent part of steam generator cable. At the time, the inspection was performed - the device was not functioning at all. It needs to be emphasized that the device in question was under arjohuntleigh service contract, preventive maintenance check was provided regularly - the last one was performed in july 2017. During that inspection, the functional test was performed- no deviations were found. All electrical components have been visually checked during each preventive maintenance (pm) and the steam generator was removed and cleaned inside minimum once a year. It needs to be emphasized that the flusher was tested according to dguv vorschrift 3 (the electrical safety test, which has to be performed as a recurrent test and after repair of medical electrical equipment according to (b)(4)) and the facility customer used the residual current device (rdc) with every flusher. A rdc is designed to disconnect a circuit when an electric leakage occurs and prevent from electric shock or burns of wire insolation. A comprehensive root cause analysis was performed to investigate this problem. From the analysis of the investigated issue, we cannot define the exact root cause. This particular device was in use for 20 years when the event occurred. Taking into account the environment in which the electrical components resided and its age it can be stated that the fire was triggered as a consequence of electrical components wear and unfortunate coincidence. The electrical components including wires, connector plugs are exceptionally exposed to wear, what is increased with wet and warm environment inside flusher. It needs to be emphasized that the plastic insulation and plug are very susceptible to aging process what makes them more stiff, fragile, breakable and less resistant to external conditions. The aging process is caused by environmental conditions, such as high temperature, exposure to ultraviolet light, visible light, atmospheric components, humidity or liquids. As per tornado flusher design, all internal parts are placed within the metal cabinet , which is a limiter for fire spread. To ensure the safety of our products the instructions for use provided together with the involved device includes the following warning: - warning: "if the machine has not been used for 72 hours the steam generator and circulation pump must be emptied. This operation must be performed by authorized personnel. " additionally, the technical manual ((b)(4) rev. B) informs the following: - information: "check the fuses as follows:? Switch off the main switch of the machine. ? Open the front door. ? Remove the relevant fuse. Check the fuse with an ohmmeter. " - information: "instruction manual, cable, switch. ? Check that the goods placing sign is posted on the wall behind the disinfector. ? Check that the isolator switch on the wall is working and that the connecting cable is undamaged and free from defects. " -warning: "we recommend using a residual current device (rcd) with the machine. " a review of mdrs for the last five (5) years (by awareness date since (b)(6) 2012 till (b)(6) 2017) revealed no reportable events related to the reported device problem. Therefore, we consider the reported malfunction as an isolated occurrence. Although there were no injuries reported, the complaint was decided to be reportable due to indication of a fire occurrence. Upon the conducted investigation and device inspection done by the arjohuntleigh representative, we were able to determined that the event was caused by wear of electrical components, but we were not able to establish the exact root cause and sequence of the events which have led to the issue occurrence. Based on all above we conclude that the device was not working up to manufacturer's specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2017-00207 |
| MDR Report Key | 6939914 |
| Date Received | 2017-10-11 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-09-10 |
| Date Facility Aware | 2017-09-11 |
| Report Date | 2017-11-29 |
| Date Reported to FDA | 2017-11-29 |
| Date Reported to Mfgr | 2017-11-29 |
| Date Mfgr Received | 2017-09-11 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 2017-10-11 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KINGA STOLINSKA |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] |
| Manufacturer City | VAXJO, 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 35115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TORNADO |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2017-10-11 |
| Model Number | SP1000AR001 |
| Device Availability | Y |
| Device Age | 20 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] VAXJO, 35115 SW 35115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-11 |