MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-25 for NAVIOS FLOW CYTOMETER, 10 COLOR/3 LASER 10 COLOR 3 LASERS A52103 manufactured by Beckman Coulter Ireland.
[98274823]
The field service engineer (fse) was dispatched and the data innovation pc was replaced with a new pc. Instrument was again operational. The computer (data innovation pc) was returned for investigation to bec and was received on january 23, 2018. The computer and its parts were assessed. The damage was too extensive within the power supply to determine the specific cause of this internal fire. However, whatever fire that did occur was completely contained within the power supply section of the computer itself, and self-extinguished on its own once power was removed. There is no evidence of any flames escaping the cabinet. It was observed that there was a large quantity of dust accumulated with the pc and the power supply itself. Bec internal identified - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[98274824]
The customer reported that the power supply for the data innovation pc of their navios instrument caught fire. There was a contained fire and smoke reported. There was no death or injury associated with the event. Medical attention was not required by anyone involved in the event. The fire department was called but upon their arrival there was no longer a fire. A fire extinguisher was not used.
Patient Sequence No: 1, Text Type: D, B5
[105524054]
The field service engineer (fse) was dispatched and the data innovation pc was replaced with a new pc. Instrument was again operational. The computer (data innovation pc) was returned for investigation to bec and was received on january 23, 2018. The computer and its parts were assessed. The damage was too extensive within the power supply to determine the specific cause of this internal fire. However, whatever fire that did occur was completely contained within the power supply section of the computer itself, and self-extinguished on its own once power was removed. There is no evidence of any flames escaping the cabinet. It was observed that there was a large quantity of dust accumulated within the pc and the power supply itself. In an abundance of caution bec has reported the event. Follow up: - important supplemental information upon further assessment, bec determined that the personal computer (pc) involved in this event was not part of the installed navios system but was used to run third party software that facilitated bi-directional communication with the facility's laboratory information system (lis). The affected personal computer is not a medical device or an accessory device to the navios system; i. E. , the navios system is independent of the third party software and is capable of processing patient samples without the use of the affected pc. The navios system was fully operational and had no reported issues related to this event. On april 10, 2018, bec followed up with the customer by phone to provide the following results of the event evaluation: the customer was informed that the investigation was completed and a replacement pc had been provided. It was observed that the returned pc was dusty and that may have been a contributing factor to the occurrence. Bec will be posting an advisory letter on our website recommending that customers add inspection and cleaning of pcs to routine laboratory maintenance. The customer was asked and stated that they had no additional questions and appreciated the feedback. The customer also stated that their internal laboratory procedure has been revised to shut down the pc at the end of each work day. Previously the pc was left on around the clock. Bec internal identifier - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105524055]
The customer reported that the power supply for the data innovation pc of their navios instrument caught fire. There was a contained fire and smoke reported. There was no death or injury associated with the event. Medical attention was not required by anyone involved in the event. The fire department was called but upon their arrival there was no longer a fire. A fire extinguisher was not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2018-00002 |
| MDR Report Key | 7220569 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-07 |
| Date of Event | 2018-01-07 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2018-01-25 |
| 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 | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVENUE, |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802874 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 331962031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIOS FLOW CYTOMETER, 10 COLOR/3 LASER |
| Generic Name | FLOW CYTOMETER |
| Product Code | OYE |
| Date Received | 2018-01-25 |
| Model Number | 10 COLOR 3 LASERS |
| Catalog Number | A52103 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER IRELAND |
| Manufacturer Address | LISMEEHAN O' CALLAHGAN'S MILLS, COUNTRY CLARE 92821 EI 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-25 |