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 2012-11-14 for TOF WATCH/NEUROMUSCULAR BLOCK MONITOR manufactured by Organon Ireland Limited.
[21416617]
Display only shows milliamperes [device malfunction]. Case description: this spontaneous report originating from (b)(6) as received from a registered nurse refers to a pt of unk age. This report concerns one pt and one device. No other co-suspects were reported. No concomitant medications were reported. On an unk date, the neuromuscular transmission monitor (tof watch) display showed only milli amperes and didn't show the depth of relaxation, nor the train of four (tof) value. The disorder was noticed when the device was taken for use on the next pt. It was noted that the display had been normal for the previous pt. The neuromuscular transmission monitor (tof watch) was more than five years old. No treatment info reported. The outcome of display shows only milli amperes is unknown. The relatedness for display shows only milliamperes is unknown for neuromuscular transmission monitor (tof watch). The device neuromuscular transmission monitor (tof watch) itself was available for investigation (reported to be available if requested by mfr). For device neuromuscular transmission monitor (tof watch), lot number was reported as 09-2004109 and serial number is not available. For neuromuscular transmission monitor (tof watch), quality investigation status: reportable malfunction/(potential) incident identified. Investigation in progress. (b)(4). Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807818-2012-00003 |
| MDR Report Key | 2891652 |
| Report Source | 00,01,05 |
| Date Received | 2012-11-14 |
| Date of Report | 2012-10-29 |
| Date Mfgr Received | 2012-10-29 |
| Date Added to Maude | 2013-02-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | MERCK, P.O. BOX 4 |
| Manufacturer City | WEST POINT PA 194860004 |
| Manufacturer Country | US |
| Manufacturer Postal | 194860004 |
| Manufacturer Phone | 2156527905 |
| Manufacturer G1 | MERCK & CO., INC. |
| Manufacturer Street | P.O. 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/NEUROMUSCULAR BLOCK MONITOR |
| Generic Name | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| Product Code | KOI |
| Date Received | 2012-11-14 |
| Lot Number | 09-2004109 |
| 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 | SWORDS, CO., DUBLIN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-14 |