MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-04-28 for STRYKERVISION FLAT-PANEL MOUNTING ARM 0240095200 manufactured by Stryker Endoscopy-san Jose.
[43888559]
(b)(4). The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed
Patient Sequence No: 1, Text Type: N, H10
[43888560]
It was reported the mintor fell off of the tower and hit a nurse in the head.
Patient Sequence No: 1, Text Type: D, B5
[51354395]
(b)(4). Since device was not returned and lot number was not provided manufacture date is not known. Alleged failure: monitor fell off a tower. Probable root cause: manufacturing nonconformity (tekna); nonconforming vesa mounting plate; weld fracture; damage during shipping /handling; missing or damaged fasteners/screws; use error. The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[51354396]
It was reported the mintor fell off of the tower and hit a nurse in the head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-00407 |
| MDR Report Key | 5615064 |
| Report Source | USER FACILITY |
| Date Received | 2016-04-28 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| Date Added to Maude | 2016-04-28 |
| 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. KIMBERLY LYNCH |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKERVISION FLAT-PANEL MOUNTING ARM |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2016-04-28 |
| Catalog Number | 0240095200 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-28 |