MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-09 for REGULATOR, VACUUM manufactured by Boehringer Laboratories, Llc.
[66877601]
Patient Sequence No: 1, Text Type: N, H10
[66877602]
The boehringer suction regulators come with a metal safety tether. According to the instructions from the manufacturer, the tether is to be attached to the suction outlet. However, that is a violation of nfpa-99 code. Manufacturer response for suction regulator safety tether, (brand not provided) (per site reporter): we have asked the rep to remove all the tethers he can find. We will not order the tethers when we order additional regulators. We will remove any missed tethers and have communicated this to the nursing staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6313781 |
| MDR Report Key | 6313781 |
| Date Received | 2017-02-09 |
| Date of Report | 2017-01-20 |
| Date of Event | 2016-12-09 |
| Report Date | 2017-01-20 |
| Date Reported to FDA | 2017-01-20 |
| Date Reported to Mfgr | 2017-01-20 |
| Date Added to Maude | 2017-02-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | REGULATOR, VACUUM |
| Product Code | KDP |
| Date Received | 2017-02-09 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOEHRINGER LABORATORIES, LLC |
| Manufacturer Address | 300 THOMS DRIVE PHOENIXVILLE PA 19460 US 19460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-09 |