MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-04 for EXTENSION ARM, 50CM 32114.453 manufactured by Richard Wolf Gmbh.
[40031259]
Photo of monitor, bracket and cart submitted. Investigation/evaluation currently in process. (b)(4) considers this report open, follow up report to be submitted once investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[40031260]
A monitor fell off its bracket striking a member of the staff on the shoulder while she was trying to position the monitor. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[47321196]
The extension arm was affected by a field safety corrective action (fsca) in 2013. Review of the documentation of the fsca from 2013 found a holder plate was mounted on the device in question at (b)(6) in 2013. Facility provided rw(b)(4) a photo of dropped monitor and the holder plate appeared to be missing. Absent of holder plate was confirmed once device was returned for investigation. Rw (b)(4) is unable to determine who removed plate, when it was removed or the reason for removing the plate. There have been no similar issues on (b)(4) extension arms with mounted holder plates since fsca in 2013. From our point of view there is no doubt about the effectiveness of the corrective action in 2013. (b)(4) considers this report to be closed. If any additional information is received concerning this event, an additional follow up report will be provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611102-2016-00002 |
| MDR Report Key | 5481926 |
| Date Received | 2016-03-04 |
| Date of Report | 2016-02-04 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-02-04 |
| Device Manufacturer Date | 2010-07-21 |
| Date Added to Maude | 2016-03-04 |
| 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. OLIVER EHRLICH |
| Manufacturer Street | 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer Phone | 043351013 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTENSION ARM, 50CM |
| Generic Name | SUPPORT ARM |
| Product Code | IOY |
| Date Received | 2016-03-04 |
| Model Number | 32114.453 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-04 |