MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2012-09-24 for TOF WATCH 79950181 manufactured by Organon Ireland Limited.
[3038080]
Screen showed a level of curarisation at 1. 3 instead of 0 while the pt was connected to the device [device malfunction]. Case description: this spontaneous report originating from (b)(6) as received from a hosp tech refers to a pt of unk age for neuromuscular transmission monitor (tof watch) (lot #30-200 90 11, serial number not available). This report concerns 1 pt and 1 device. No other co-suspects or concomitant medications were reported. On an unk date, the hosp tech reported that the tofwatch screen showed a level of curarisation at 1. 3 instead of 0 while the pt was connected to the device. No treatment info was reported. The hosp tech tried another unspecified device which showed the value of 0. The outcome is unk. The device neuromuscular transmission monitor (tof watch) itself was available for investigation. Quality investigation status: reportable malfunction/incident identified. Investigation in progress. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10278734]
Reportable malfunction/incident identified. Investigation in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807818-2012-00002 |
| MDR Report Key | 2784974 |
| Report Source | 00,01,05 |
| Date Received | 2012-09-24 |
| Date of Report | 2012-09-04 |
| Date Mfgr Received | 2012-09-04 |
| Date Added to Maude | 2013-01-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 19486000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19486 0004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOF WATCH |
| Generic Name | NONE |
| Product Code | KOI |
| Date Received | 2012-09-24 |
| Model Number | 79950181 |
| Lot Number | 30-2009011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGANON IRELAND LIMITED |
| Manufacturer Address | SWORDS CO, DUBLIN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-24 |