MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-30 for EPOC BLOOD ANALYSIS SYSTEM UNKNOWN manufactured by Epocal Inc.
[128917321]
This event was reported to mhra by the customer prior to epocal being notified of the event. Reporter confirmed that no injury/adverse event happened, however we were unable to obtain additional information from the reporter despite three attempts at follow-up. Epocal cannot rule out the possibility of a serious deterioration in the state of health if the event were to recur. Despite three attempts at follow-up with the reporting institution, the company was unable to confirm that an epoc device was involved in this event or to obtain lot numbers involved or relevant information (sample handling details, obtained po2 results with epoc and comparative instrument, expected po2 value, any patient condition at the time of testing) in order to investigate further. Although no patient injury occurred, the initial reporter classified the incident as a near miss, therefore the company is reporting this event on the assumption that if the event were to recur it would be likely to cause or contribute to a deterioration in state of health. Complaint history results: for the period (b)(6) 2018 to (b)(6) 2018, there was one other complaint related to a high po2 bias received by the manufacturer in addition to this case reported to mhra. The other complaint was initiated in (b)(6) and the manufacturer investigation revealed that the reported bias was in fact within product specifications (allowable total error). Pre-analytical factors were also noted (delay in testing). The manufacturer has not been notified of any adverse events related to high po2 results. Malfunction could not be confirmed as no lot information or data was provided by the reporting institution. Based on the in-house performance data as well as received complaints, no evidence of a product performance issue is found. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128917322]
A complaint ((b)(4)) was received from a customer in the (b)(6). The customer reported this case to the medicines and healthcare products regulatory agency (mhra). As per reporter: "the blood oxygen level readings appeared to be consistently high on one day only ((b)(6) 2018) and did not correlate with oxygen saturation readings taken concurrently or with the levels of oxygen the patient was on. No injury per se but could be considered a near miss if i hadn't noticed a pattern and adjusted oxygen levels accordingly".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004959793-2018-00002 |
| MDR Report Key | 8120063 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. AMANDA BARRIAGE |
| Manufacturer Street | 855 BROOKFIELD ROAD |
| Manufacturer City | K1V 2S5 |
| Manufacturer Country | CA |
| Manufacturer Postal | K1V 2S5 |
| Manufacturer G1 | EPOCAL INC |
| Manufacturer Street | 855 BROOKFIELD ROAD |
| Manufacturer City | OTTAWA, ONTARIO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPOC BLOOD ANALYSIS SYSTEM |
| Generic Name | EPOC BLOOD ANALYSIS SYSTEM |
| Product Code | CGL |
| Date Received | 2018-11-30 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPOCAL INC |
| Manufacturer Address | 855 BROOKFIELD ROAD OTTAWA, ONTARIO K1V 2S5 CA K1V 2S5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-30 |