MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-03-22 for GETINGE 8666 * manufactured by Getinge Disinfection Ab.
[198731]
A model 8666 washer/disinfector caught fire and was destroyed beyond repair within central processing dept. The fire was contained within the enclosure of the washer. Some smoke and water damage occurred to the area due to the activation of the sprinkler system. The local fire dept put out the fire and assured the area was safe. Evacuation was limited to the immediate area (basement of hospital). No one was injured. The problem and cause is currently not fully known and is under investigation. The unit was removed from that facility and is being retained for investigation purposes.
Patient Sequence No: 1, Text Type: D, B5
[208843]
High winds and electrical storms were present during the day of this event. Over-voltage or high transient conditions were likely at the time of the incident. The investigation shows that there was an addition of a model knight trak ii peristaltic pumping system that was interfaced to the 8666 washer/disinfector. The knight trak ii system is modular. A knight signal interface module was installed within the lower cabinetry of co's device. This module provides an input and output interface between co's equipment and the knight pumping system. This knight signal module was identified as being the likely origin of the fire, based upon it being the most extensively damaged of all componnents and the observed fire damage patterns. There were no design changed made to the 8666 washer/disinfector that are related to the event. Knight, inc is not a medical device mfr nor is their pumping system a medical device. It is a separate system. Primarily, these pumping systems are distributed to laundry and research industries and are currently used on high volume, commercial washing equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616031-2001-00001 |
| MDR Report Key | 322642 |
| Report Source | 07 |
| Date Received | 2001-03-22 |
| Date of Report | 2001-03-21 |
| Date of Event | 2001-02-25 |
| Date Mfgr Received | 2001-02-25 |
| Device Manufacturer Date | 1999-03-01 |
| Date Added to Maude | 2001-03-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FREDERICK CATT |
| Manufacturer Street | 1777 E HENRIETTA RD |
| Manufacturer City | ROCHESTER NY 146233133 |
| Manufacturer Country | US |
| Manufacturer Postal | 146233133 |
| Manufacturer Phone | 7162725013 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GETINGE |
| Generic Name | WASHER/DISINFECTOR |
| Product Code | MDZ |
| Date Received | 2001-03-22 |
| Model Number | 8666 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 312105 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADAISGATAN 11 P.O. BOX 1505 VAXJO SW S-351 15 |
| Baseline Brand Name | GETINGE |
| Baseline Generic Name | WASHER/DISINFECTOR |
| Baseline Model No | 8666 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K920413 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-03-22 |