MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for SERVICE MOD ACC., INNOVATIVE FP, TUBE 500020475 manufactured by Berchtold Corp.
[40543537]
It was reported that the monitor arm allegedly detached from the bracket and fell while the monitor was being adjusted. There was no patient involvement, no injuries and no adverse events reported. The investigation is ongoing and stryker will perform a supplemental once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[40543538]
It was reported that the monitor arm allegedly detached from the bracket and fell while the monitor was being adjusted. There was no patient involvement, no injuries and no adverse events reported.
Patient Sequence No: 1, Text Type: D, B5
[56173467]
It was reported that an innovative monitor arm fell from the teletom tube mount. The structural screw at the bottom of the mount allegedly backed out. In order to back out, this screw would have had to loosen from over-use or misuse. The failure could have also been caused by either improper maintenance by the account or improper installation. With proper installation, maintenance, and use, it is unlikely that the screw could have backed out causing the separation. The installation manual for this unit is maintained by innovative as they provide and manufacture the arm. In addition, the present models of teletom (4 and 6 series) are sold exclusively with cim arms; innovative arms have been removed as an option from the configurator. The stryker teletom installation manual will not be updated to include any new details on installing innovative arms since these arms are no longer sold with teletom booms.
Patient Sequence No: 1, Text Type: N, H10
[56173468]
It was reported that the monitor arm allegedly detached from the bracket and fell while the monitor was being adjusted. There was no patient involvement, no injuries and no adverse events reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001220865-2016-00008 |
| MDR Report Key | 5496393 |
| Date Received | 2016-03-11 |
| Date of Report | 2016-02-16 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-02-16 |
| Date Added to Maude | 2016-03-11 |
| 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 | MR. ADAM GORZEMAN |
| Manufacturer Street | 1950 HANAHAN ROAD |
| Manufacturer City | CHARLESTON SC 29406 |
| Manufacturer Country | US |
| Manufacturer Postal | 29406 |
| Manufacturer Phone | 8435696100 |
| Manufacturer G1 | BERCHTOLD CORP |
| Manufacturer Street | 1950 HANAHAN ROAD |
| Manufacturer City | CHARLESTON SC 29406 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERVICE MOD ACC., INNOVATIVE FP, TUBE |
| Generic Name | EDS BOOM |
| Product Code | BRY |
| Date Received | 2016-03-11 |
| Catalog Number | 500020475 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD CORP |
| Manufacturer Address | 1950 HANAHAN ROAD CHARLESTON SC 29406 US 29406 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-11 |