MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-22 for TORNADO FD1810 manufactured by Getinge Ic Production Poland Sp. Z O.o.
[175835395]
Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4). Currently, these products are to be handled by arjohuntleigh ab? S complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4). The involved device was evaluated by the arjo representative and found unusable, hence it was removed from service. The investigations on-going and further information will be provided in the next report.
Patient Sequence No: 1, Text Type: N, H10
[175835396]
Arjo was notified about an event with involvement of tornado flusher. It was reported that the device's steam generator started the fire, which burned the quick connect cable and all components around that part. No other part was damaged. The facility personnel used the extinguisher to stop the fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2020-00009 |
| MDR Report Key | 9615562 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-22 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2015-06-23 |
| Date Added to Maude | 2020-01-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 688282467 |
| Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001 TANGUAY STREET |
| Manufacturer City | MAGOG J1X5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X5Y5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TORNADO |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2020-01-22 |
| Model Number | FD1810 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE IC PRODUCTION POLAND SP. Z O.O |
| Manufacturer Address | UL. SZKOLNA 30, PLEWISKA PLEWISKA PL-62064 PL PL-62064 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-22 |