MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-07-03 for FLOTRAC CONNECTING CABLE APCO9X2 manufactured by Edwards Lifesciences.
[3690509]
It was reported that after 1~2 hours of use, the blood pressure value displayed on the nihon kohden bedside monitor attenuated 20~30 mmhg lower than at the start of measurement; however, the details of the value were unable to be obtained. When the event transpired, no error messages were observed, but the customer surmised that the value was not reflective of the patient? S status. There was no report of inappropriate treatment resulting from the suspect value. It was noted that the issue was only observed when the nihon kohden monitor was used with a flotrac connected to a vigileo monitor, and was not observed with a disposable pressure transducer. The flotrac was replaced; however, replacement of the flotrac did not improve the symptom. The customer suspected a malfunction occurred with either the vigileo monitor or an apco9 cable. Four (4) suspect devices were identified and reported as potentially related to this event, as the serial numbers for the suspect devices were not specified and all likely units were reported.
Patient Sequence No: 1, Text Type: D, B5
[10880484]
No evaluation has been performed as the cable is expected to be returned for evaluation and has not yet been received. A follow-up submission will be submitted to communicate the evaluation and investigation results.
Patient Sequence No: 1, Text Type: N, H10
[11047503]
This follow-up is submitted to communicate the evaluation results and reference the related mfr. Reports associated with the reported event: vigileo monitor 2015691-2019-20535, vigileo monitor 2015691-2013-20537, and apco9 flotrac connection cable 9 ft (274 cm) 2015691-20541. The cable was manufactured 10-mar-2010. The device history record was unavailable for review. Examination of the returned cable was unable to replicate the customer? S complaint. The cable was evaluated and passed cirris functional testing without incident. No physical damage was observed during the visual inspection. It is unknown whether procedural processes or a specific circumstance played a role in the reported experience, as no fault could be determined and the evaluation results did not confirm the reported issue with this device or any of the related devices/complaints. The cable will be returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2013-20539 |
| MDR Report Key | 3205940 |
| Report Source | 01,06 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-06-06 |
| Date of Event | 2013-06-05 |
| Date Mfgr Received | 2013-06-06 |
| Device Manufacturer Date | 2010-03-10 |
| Date Added to Maude | 2013-07-03 |
| 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 | MR. DAVID VU |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502435 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOTRAC CONNECTING CABLE |
| Generic Name | CONNECTING CABLE |
| Product Code | ISN |
| Date Received | 2013-07-03 |
| Model Number | APCO9X2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-03 |