MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-27 for EPOC HOST 10736387 manufactured by Epocal Inc..
[182564762]
The patient's wristband was corrected, but the results in the epoc and edm were still mismatched to another patient. The customer called into siemens technical solutions to determine if and how patient results can be edited, however, the customer was told that only a comment can be added to describe the event. No lab tests were performed on the other baby. There is no allegation of any harm or adverse events and no patient results or treatments were affected. The system is operational and the event is classified as a use/user error (accidental misuse).
Patient Sequence No: 1, Text Type: N, H10
[182564763]
The customer stated a nicu nurse drew a heel stick sample and ran an epoc cap-care tube, pt. Id# (b)(6). The results were not transferring over into the patient's chart (powerchart emr), and it was then discovered that the patient had another patient wristband on, pt. Id# (b)(6). The incorrect barcode was scanned. The patient's wristband was corrected, but the results in the epoc and edm were still mismatched to another patient. There were no lab tests performed on the other baby. No treatment or lack of treatment occurred as a result of the user error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00007 |
| MDR Report Key | 9765338 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-15 |
| Date Mfgr Received | 2020-02-15 |
| Date Added to Maude | 2020-02-27 |
| 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 | FELIX AKINRINOLA |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 7052212 |
| Manufacturer G1 | EPOCAL INC. |
| Manufacturer Street | 2060 WALKLEY ROAD |
| Manufacturer City | OTTAWA, ONTARIO K1G 3P5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K1G 3P5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPOC HOST |
| Generic Name | EPOC |
| Product Code | CGL |
| Date Received | 2020-02-27 |
| Catalog Number | 10736387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPOCAL INC. |
| Manufacturer Address | 2060 WALKLEY ROAD OTTAWA, ONTARIO K1G 3P5 CA K1G 3P5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |