MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-10-09 for ISU, BSC, STD, CW DOM 8700-0000-801 manufactured by Ohio Medical Corporation.
[5102372]
The device is a vacuum regulator intended to regulate suction to remove body fluids. On (b)(6) 2014, it was noted that 14 devices which had been returned for repair contained diaphragms which had significant tears in them after device life of less than 6 months. At the time on quality assurance awareness on 07/31/2014, previous returns were reviewed further to determine if any other newer devices had been returned with confirmed damaged diaphragms. One additional device was noted. It has been determined that a tear in the regulator diaphragm while in use (after vacuum has been set) could result in an increase in vacuum to the patient than what had been originally set.
Patient Sequence No: 1, Text Type: D, B5
[12367454]
Device is a vacuum regulator. The device achieves its function via a regulator module that is equipped with a diaphragm. The user filed a complaint that the regulator gauge was jumpy. During the investigation of the returned devices it was discovered that the malfunctioning units had their diaphragms torn. The user did not report any patient involvement nor any adverse event. The user also did not file a form fda-3500a. The manufacturer is filing form fda-3500a because this was a malfunction that if it were to recur, it would have the potential to cause some patient harm. Investigation into the root cause in ongoing as of the date of this report and it has not yet been determined the extent to which remedial action would be appropriate to prevent an unreasonable risk of substantial harm to public health. This malfunction was previously reported on 08/29/2014 (mfr report # 1419185-2014-00003), however, multiple devices were included on that report in error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419185-2014-00011 |
| MDR Report Key | 4181760 |
| Report Source | 99 |
| Date Received | 2014-10-09 |
| Date of Report | 2014-10-09 |
| Date of Event | 2014-05-12 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-10-22 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1111 LAKESIDE DR. |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISU, BSC, STD, CW DOM |
| Generic Name | VACUUM REGULATOR |
| Product Code | KDP |
| Date Received | 2014-10-09 |
| Returned To Mfg | 2014-06-27 |
| Model Number | 8700-0000-801 |
| Lot Number | ISU137461 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | GURNEE IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-09 |