MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-11 for TOF WATCH SX manufactured by Organon Ireland Limited.
[50621335]
The neuromuscular transmission monitor (tof watch sx) was available for investigation (current location of the device is (b)(6)). For neuromuscular transmission monitor (tof watch sx), the lot number is not available and the serial number was reported as (b)(4). For neuromuscular transmission monitor (tof watch sx), quality investigation status: reportable malfunction/potential incident identified. Investigation in progress. Add'l info is expected.
Patient Sequence No: 1, Text Type: N, H10
[50621336]
Case description: this spontaneous initial report originating from (b)(6) as received from a physician via a study coordinator, refers to a (b)(6) female pt. The pt was enrolled in the study entitled (b)(6) trial to compare the use of deep or standard neuromuscular blockade in combination with low or standard insufflation pressures using a 2x2 factorial design in patients undergoing laparoscopic cholecystectomy (protocol # (b)(4) also known as (b)(4)). This report concerns one pt and one device. The pt used neuromuscular transmission monitor (tof watch sx) from (b)(6) 2013" (product used for unk indication). The study site randomized the pt on (b)(6) 2013, but there were problems with the neuromuscular transmission monitor (tof watch sx). The study coordinator managed to do calibration but after that they had some difficulties with tof measurements and then suddenly in the tof watch screen appeared an image of wrench and error message. The device was connected to the pt at the time of the event. Then the device turned off by itself and did not work anymore. Before this, nothing happened which could explain this happened. New battery was also changed. The device was used according to the instruction leaflet. Info on the operator of the device is not reported, however, the operator was trained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807818-2013-00001 |
| MDR Report Key | 3622115 |
| Date Received | 2013-12-11 |
| Date of Report | 2013-12-02 |
| Date Mfgr Received | 2013-12-02 |
| Date Added to Maude | 2014-02-11 |
| 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 Street | PO BOX 4 |
| Manufacturer City | WEST POINT PA 194860004 |
| Manufacturer Country | US |
| Manufacturer Postal | 194860004 |
| Manufacturer Phone | 2156527905 |
| Manufacturer G1 | MERCK & CO., INC. |
| Manufacturer Street | PO BOX 4 |
| Manufacturer City | WEST POINT PA 194860004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 194860004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOF WATCH SX |
| Generic Name | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| Product Code | KOI |
| Date Received | 2013-12-11 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGANON IRELAND LIMITED |
| Manufacturer Address | DRYNAM ROAD SWORDS CO., DUBLIN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-11 |