MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-06 for ED PULSECHECK 5.5 manufactured by Picis Clinical Solutions, Inc..
[31080704]
Picis clinical solutions received an enhancement request on (b)(6)-2015: "please, please, please, please!!! We've recently had two near misses with patient weights. The most recent had to do with charting pounds in the kg field. We really need the lbs field to not be available. " further investigation determined that there were no reported patient incidents related to the enhancement request. The ed pulsecheck product currently has two template fields for the documentation of a patient's weight, a field to document in pounds and a field to document weight in kilograms. The clinician must document in the field that corresponds to the units in which the weight was measured. The near misses reported were related to a clinician documenting inaccurate information into a clearly labeled template field within ed pulsecheck. Picis clinical solutions, inc. Is planning to release the next version of the ed pulsecheck product. This version of ed pulsecheck (v5. 6) will include an enhancement option to only display the kg field for weight data entry. This enhancement may minimize the risk of a data entry error, although the enhancement does not prevent the risk of data entry error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005244943-2015-00004 |
| MDR Report Key | 5207139 |
| Date Received | 2015-11-06 |
| Date of Report | 2015-10-22 |
| Date Mfgr Received | 2015-10-22 |
| Date Added to Maude | 2015-11-06 |
| 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 | MS. KERRY ARMSTRONG |
| Manufacturer Street | 100 QUANNAPOWITT PARKWAY SUITE 405 |
| Manufacturer City | WAKEFIELD MA 01880 |
| Manufacturer Country | US |
| Manufacturer Postal | 01880 |
| Manufacturer Phone | 7815573000 |
| Manufacturer G1 | PICIS CLINICAL SOLUTIONS, INC. |
| Manufacturer Street | 100 QUANNAPOWITT PARKWAY SUITE 405 |
| Manufacturer City | WAKEFIELD MA 01880 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01880 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ED PULSECHECK |
| Generic Name | SOFTWARE, TRANSMISSION AND STORAGE |
| Product Code | NSX |
| Date Received | 2015-11-06 |
| Model Number | 5.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PICIS CLINICAL SOLUTIONS, INC. |
| Manufacturer Address | 100 QUANNAPOWITT PARKWAY SUITE 405 WAKEFIELD MA 01880 US 01880 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-06 |