MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-11-07 for MONITOR FOR COMPARTMENTAL PRESSURE MONITORING 530.411 manufactured by Synthes Monument.
[3024252]
A report was received regarding a compartmental pressure monitoring system that did not read/display an accurate measurement. The healthcare provider powered on the monitor in order to "zero out" the device. The probe was then inserted into the tibial region of the patient which gave a reading of 60mmhg. The health care provider determined by clinical suspicion that the reading of 60mmhg was too high and not consistent with the condition of the patient which was described as soft. After removing the probe from the patient the device display indicated 30mmhg. This is report #1 of 2 for the same event.
Patient Sequence No: 1, Text Type: D, B5
[10267682]
Device was used for diagnosis. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process.
Patient Sequence No: 1, Text Type: N, H10
[10464210]
The device history record review revealed the part lot was made to conformed to specification requirements and verified per the certificate of compliance. The monitor was inspected and accepted to the synthes inspection there were no mrrs, ncrs, or complaint-related issues with this lot. A manufacturing evaluation was conducted. The device was received intact, no apparent damage. The supplier conducted an evaluation on the device and determined that the "chip was badly soiled" and the "dry-wet-temperature drift was beyond the accepted tolerance. " the device history record review revealed that the products were shipped within specification and passed all of the required functional testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2012-01133 |
| MDR Report Key | 2823137 |
| Report Source | 05,07 |
| Date Received | 2012-11-07 |
| Date of Report | 2012-10-11 |
| Date of Event | 2012-10-11 |
| Date Mfgr Received | 2012-10-11 |
| Device Manufacturer Date | 2004-02-10 |
| Date Added to Maude | 2013-02-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE BURKE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONITOR FOR COMPARTMENTAL PRESSURE MONITORING |
| Generic Name | COMPART. PRESSURE MONITOR |
| Product Code | LXC |
| Date Received | 2012-11-07 |
| Returned To Mfg | 2012-10-30 |
| Catalog Number | 530.411 |
| Lot Number | 000248 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-07 |