MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for SYSMEX POCH-100I 02318618 manufactured by Sysmex Corporation.
[118881375]
The pcb is made of flame resistant materials, but excessive heat from the malfunction poses a risk of inhalation of smoke and/or harmful vapors from scorched materials. The pcb is not accessible to the user, and is grounded, reducing the potential for harm due to shock. Investigation for root cause is ongoing by sysmex corporation (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118881376]
A user in (b)(6) detected a burning odor emanating from the analyzer after turning the power on. The user immediately disconnected the power. A service engineer was dispatched and found a burnt printed circuit board (pcb). No users sought medical attention due to the burning odor.
Patient Sequence No: 1, Text Type: D, B5
[139892937]
The sysmex poch-100i instructions for use (ifu), chapter 7 - safety information & waste disposal, section 7. 1 safety informations, warns the user: "if the instrument emits unusual odors or smoke, or if the instrument leaks: switch off immediately and unplug the power cable. Contact your sysmex service representative. " the user immediately disconnected the power. Sysmex corporation (b)(4) (s-corp) performed the investigation. S-corp identified the dc/dc converter mounted on the liquid crystal display (lcd) control board (pcb no. (b)(4)) failed, and requested an investigation from the supplier of the pcb. Due to the charring of pcb no. (b)(4), investigation was impossible. Root cause was undetermined. S-corp replaced the analyzer. Pcb no. (b)(4) is not accessible to the user, and is grounded, reducing the potential for harm due to shock. The pcb is made of flame resistant materials and covered with a metal shield.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000515253-2018-00013 |
| MDR Report Key | 7830713 |
| Date Received | 2018-08-29 |
| Date of Report | 2019-02-25 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2004-02-03 |
| Date Added to Maude | 2018-08-29 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JASNA FRONTZ |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439753 |
| Manufacturer G1 | SYSMEX CORPORATION |
| Manufacturer Street | 314-2 KITANO NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA, HYOGO 675-0011 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 675-0011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYSMEX POCH-100I |
| Generic Name | AUTOMATED HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2018-08-29 |
| Model Number | POCH-100I |
| Catalog Number | 02318618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORPORATION |
| Manufacturer Address | 314-2 KITANO NOGUCHI-CHO KAKOGAWA, HYOGO 675-0011 JA 675-0011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |