MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-11-07 for ODP/EDM PROBE 9050-7201 manufactured by Deltex Medical Ltd.
[338165]
In 2003, one of the clinical trainers received a telephone call from a charge nurse in the intensive care unit stating that the probe boot (distal end of probe) had come away from the rest of the probe body. The hospital was then phoned back and the charge nurse stated the following. "nurse had inserted the probe this morning at around 10 a. M. And it was working fine. As nurse had another pt with a probe in, nurse was using the cardioq (monitor) between the two pts. Nurse was using the cardioq this afternoon on their pt, but nurse was unable to get a good signal as before. Charge nurse took the probe out of the pt, as nurse was not going to alter any more therapy for now. Charge nurse cleaned it with a tissue so that nurse could put it back in a bag and keep it in case nurse needed to use it again on the pt. While charge nurse was cleaning it, the tip came off in their hand - charge nurse was not using excess force, just wiping it. That is when their colleague called clinical trainer. The next day the probe was collected from the unit. Charge nurse has completed an internal incident report form (ir1 form) and copies can be obtained from the risk management department of hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680933-2003-00001 |
| MDR Report Key | 527312 |
| Report Source | 05 |
| Date Received | 2003-11-07 |
| Date of Report | 2003-10-30 |
| Date of Event | 2003-10-28 |
| Date Facility Aware | 2003-10-28 |
| Report Date | 2003-10-30 |
| Date Reported to FDA | 2003-11-03 |
| Date Mfgr Received | 2003-10-28 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2004-06-02 |
| 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 | TERMINOS ROAD |
| Manufacturer City | CHICHESTER, WEST SUSSEX P0198TX |
| Manufacturer Country | UK |
| Manufacturer Postal | P019 8TX |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ODP/EDM PROBE |
| Generic Name | OESOPHAGEAL DOPPLER PROBE |
| Product Code | DPW |
| Date Received | 2003-11-07 |
| Returned To Mfg | 2003-10-30 |
| Model Number | ODP/EDM PROBE |
| Catalog Number | 9050-7201 |
| Lot Number | 1057 |
| ID Number | SHELF LIFE |
| Device Expiration Date | 2006-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 516480 |
| Manufacturer | DELTEX MEDICAL LTD |
| Manufacturer Address | TERMINUS RD. CHICHESTER, WEST SUSSEX UK P019 8TX |
| Baseline Brand Name | ODP/EDM PROBE |
| Baseline Generic Name | OESOPHAGEAL DOPPLER PROBE |
| Baseline Model No | ODP/EDM PROBE |
| Baseline Catalog No | 9050-7201 |
| Baseline ID | SHELF LIFE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-07 |