MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-04-24 for PROBE FOR CPMS 530.412 manufactured by N/i.
[12180830]
Additional narrative: the actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition could not be confirmed. An assignable root cause was not determined. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[13116862]
Correction: the manufacturer city was inadvertently documented as depuy synthes power tools. This product probe for cpms is not manufactured by depuy synthes and is manufactured by: mipm. All further investigation will be performed by mipm.
Patient Sequence No: 1, Text Type: N, H10
[22136627]
It was reported from (b)(6) that during a compartmental pressure monitoring surgical procedure, it was discovered that the probe device displayed an? Error code?. According to the reporter, the procedure was being performed to determine if surgery was an option for chronic exertional compartment syndrome. There was a twenty five minute delay to the planned surgical procedure. An identical spare device was available for use. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[22306822]
Initial reporter? S phone number: (b)(6). The manufacturer? S information was unknown. Device manufacture date was unknown. The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2014-10911 |
| MDR Report Key | 3770831 |
| Report Source | 01,06,07 |
| Date Received | 2014-04-24 |
| Date of Report | 2014-03-28 |
| Date of Event | 2014-03-07 |
| Date Mfgr Received | 2015-02-24 |
| Date Added to Maude | 2014-06-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | N/I N/I |
| Manufacturer Street | F OSKAR-VON-MILLER STRASSE 6 |
| Manufacturer City | MAMMENDORF, 82291 PA 19380N/I |
| Manufacturer Country | GM |
| Manufacturer Postal | 19380N/I |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBE FOR CPMS |
| Generic Name | MONITOR, PRESSURE, INTRACOMPARTMENT |
| Product Code | LXC |
| Date Received | 2014-04-24 |
| Returned To Mfg | 2014-04-11 |
| Catalog Number | 530.412 |
| Lot Number | 25-1585 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | N/I |
| Manufacturer Address | N/I N/I US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-24 |