MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-17 for PTS ISU 1251 8701-1251-905 manufactured by Ohio Medical Llc.
[47740286]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[47740287]
User facility report (b)(4) was received by manufacturer on (b)(6) 2016 stating "the vacuum regulator comes loose from wall outlet. At times the regulator leans forward compromising suction. " initial reporter was contacted on (b)(6) 2016 and stated that the device was not in use during occurence. She stated that she was told "those regulators always have that problem" but could not provide any further detail on what degree of "compromising suction" as stated in user report had occured as she was not present. Return material authorization was opened and initial reporter stated that device would be returned for evaluation. Multiple attempts have been made to gather further information and to have device in question returned. On (b)(6) 2016 (b)(6) stated "as far as i can tell, it [device] seems to be in good working condition. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2016-00028 |
| MDR Report Key | 5732897 |
| Date Received | 2016-06-17 |
| Date of Report | 2016-06-17 |
| Date Mfgr Received | 2016-05-16 |
| Device Manufacturer Date | 2014-04-11 |
| Date Added to Maude | 2016-06-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JESSICA BARRILE |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478556318 |
| Manufacturer G1 | OHIO MEDICAL LLC |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PTS ISU |
| Generic Name | VACUUM REGULATOR |
| Product Code | KDP |
| Date Received | 2016-06-17 |
| Model Number | 1251 |
| Catalog Number | 8701-1251-905 |
| Lot Number | ISU147092 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL LLC |
| Manufacturer Address | 1111 LAKESIDE DR GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-17 |