MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-02-26 for IMPAX CV REPORTING IMPAX CV 7.4SU3 HF1 NA manufactured by Agfa Healthcare Corp.
[3194624]
On (b)(6) 2013, a lead echo sonographer alerted agfa that ultrasound measurements were inserted in the wrong location for 2 different phillips ie3 ultrasound carts. The cardiologist was concerned that erroneous measurements resulted in incorrect diagnosis as the mitral regurgitation is rated higher than it actually is. Additionally, the specific measurement values were not consistent with the acquired image studies, agfa's investigation of this mdr revealed that in 2012 a correction was implemented by a agfa clinical analyst by reconfiguring the customer's system to eliminate the type of mismapping seen in this current mdr. (the 2012 event and correction were reported via fda mdr 1225058-2012-00002). This past correction was mistakenly reverted to its previous configuration in impax cv for philips ie-33 ultrasound carts by an agfa professional services person, thus re-enabling the errors initially found on (b)(6) 2012. On (b)(4) 2013, agfa corrected the issue by reconfiguring the customer's system and eliminating the mismapping. The customer has confirmed the implemented correction has fixed the problem and there are no further issues. No reports of pt harm were reported during this event.
Patient Sequence No: 1, Text Type: D, B5
[10558942]
The customer's software version used is: version: 2. 04. 67. 00. Su2, release date: 2010-02-06 (also called cv 7. 4 su3). Agfa's investigation of this mdr revealed that in 2012 a correction was implemented by a agfa clinical analyst by reconfiguring the customer's system to eliminate the type of mismapping seen in this current mdr. (the 2012 event and correction were reported via fda mdr 1225058-2012-00002). This past correction was mistakenly reverted to its previous configuration in impax cv for philips ie-33 ultrasound carts by an agfa professional services person, thus re-enabling the errors initially found on (b)(6) 2012. On (b)(4) 2012, agfa corrected the issue by reconfiguring the customer's system and eliminating the mismapping. The customer has confirmed the implemented correction has fixed the problem and there are no further issues. No reports of pt harm were reported during this event. During the investigation it was discovered 185 study dates were impacted and included 1415 mrns (medical record numbers). Agfa will submit a mdr to the fda for each of the 185 study dates and include the specific mrns referencing each study date. The mdr submission names for the entire event will include: 1225058-2013-00001 through 1225058-2013-00185. Study date: (b)(6) 2011. Mrns: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225058-2013-00063 |
| MDR Report Key | 3001247 |
| Report Source | 07 |
| Date Received | 2013-02-26 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-01-29 |
| Date Mfgr Received | 2013-01-29 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2013-05-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBORAH HUFF |
| Manufacturer Street | 10 SOUTH ACADEMY ST. |
| Manufacturer City | GREENVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211754 |
| Manufacturer G1 | AGFA HEALTHCARE CORP |
| Manufacturer Street | 1 CROSSWIND RD. |
| Manufacturer City | MISQUAMICUT RI 02891 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPAX CV REPORTING |
| Generic Name | IMPAX CV REPORTING |
| Product Code | LMB |
| Date Received | 2013-02-26 |
| Model Number | IMPAX CV 7.4SU3 HF1 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGFA HEALTHCARE CORP |
| Manufacturer Address | MISQUAMICUT RI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-26 |