MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-02 for STAT PROFILE PRIME PLUS ANALYZER SYSTEM 57400 manufactured by Nova Biomedical Corp..
[183877626]
A device history record (dhr) review was performed on the analyzer in question, pn 57400, serial number (b)(4) and the microsensor card that was in use at the time of erroneous po2 result, pn 61614, lot number 19361008. The dhr reviews did not show any failures that would cause an erroneous po2 blood result to occur. Root cause cannot be determined at this time. Nova biomedical will monitor for similar issues.
Patient Sequence No: 1, Text Type: N, H10
[183877627]
The customer reported that the prime plus analyzer had a discrepant po2 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219029-2020-00008 |
| MDR Report Key | 9776004 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-02 |
| 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 Contact | MS. TAYLOR WARD |
| Manufacturer Street | 200 PROSPECT ST |
| Manufacturer City | WALTHAM, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 6473700153 |
| Manufacturer G1 | NOVA BIOMEDICAL CORP. |
| Manufacturer Street | 200 PROSPECT ST |
| Manufacturer City | WALTHAM, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAT PROFILE PRIME PLUS ANALYZER SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | CHL |
| Date Received | 2020-03-02 |
| Model Number | 57400 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL CORP. |
| Manufacturer Address | 200 PROSPECT ST WALTHAM, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |