MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-05-10 for APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205 manufactured by Life Technologies Holdings Pte Ltd..
[44891971]
On (b)(4) 2016 a (b)(4) scientific field service engineer visited the (b)(6) to respond to the user report and service the 7500 fast dx instrument after the incident. The engineer noted the laptop computer was on located on a holder on top of the 7500 fast dx instrument. The holder was made of metal with rubber feet and rubber pads. The laptop mouse was placed on a mousepad beside the 7500 fast dx instrument. The instrument and mousepad were located on a lab bench made of metal with a plastic resin top. The engineer visually inspected the 7500 fast dx and noticed four (4) loose screws in back of the instrument. It appeared that the loose screws caused the instrument cover to become loose. The cover was removed from the instrument and grounding cables inside the instrument were visually inspected for attachment to correct sources. All grounding cables inside the instrument were attached correctly. The engineer then tightly screwed in the cover to close the instrument. The laptop and instrument were both plugged into a cyber power ups / surge protector. The engineer checked the electrical outlet for proper grounding using a line monitoring kit. The outlet did not have any defects. The power cord for the laptop was replaced and the instrument and laptop were turned on. Both the instrument and laptop were operating correctly. Self-tests on the 7500 fast dx system were run. The instrument passed specifications. No visual signs of electrical damage on the instrument or laptop were observed. No signs of software corruption from electrical damage were observed. On (b)(4) 2016 a representative from (b)(4) contacted the reporter, (b)(6), to inquire about adverse health effects from the incident. The user reported no adverse health issues and stated the facility is waiting to install a static mat, or other safety measure, before using the instrument again.
Patient Sequence No: 1, Text Type: N, H10
[44891972]
A user reported a "shock" while wearing gloves that felt like a surge and vibration. The user had one hand on the computer mouse and one hand on the computer keyboard with the 7500 fast dx instrument turned on. The sensation lasted a few seconds and caused the user to feel tired and a slight tingling sensation in their forehead. The user reported recovering from the initial shock quickly. They were sent to the emergency room for precaution and were released by the emergency room doctor with no further hospitalization. No adverse reactions were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003673482-2016-00003 |
| MDR Report Key | 5643862 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-05-10 |
| Date of Report | 2016-04-11 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-04-11 |
| Device Manufacturer Date | 2014-07-09 |
| Date Added to Maude | 2016-05-10 |
| 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 | KELLI TANZELLA |
| Manufacturer Street | 3175 STALEY ROAD |
| Manufacturer City | GRAND ISLAND NY 14072 |
| Manufacturer Country | US |
| Manufacturer Postal | 14072 |
| Manufacturer Phone | 7167743122 |
| Manufacturer G1 | LIFE TECHNOLOGIES HOLDINGS PTE LTD. |
| Manufacturer Street | BLK 33, MARSILING INDUSTRIAL ESTATE ROAD 3, NO. 07-06 |
| Manufacturer City | SINGAPORE NORTH WEST, SINGAPORE 739256 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 739256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR |
| Generic Name | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR |
| Product Code | NSU |
| Date Received | 2016-05-10 |
| Catalog Number | 4407205 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE TECHNOLOGIES HOLDINGS PTE LTD. |
| Manufacturer Address | BLK 33, MARSILING INDUSTRIAL ESTATE ROAD 3, NO. 07-06 SINGAPORE NORTH WEST, SINGAPORE 739256 SN 739256 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-10 |