MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-07-18 for PKG., STRYKERVISION MOUNT 0240095200 manufactured by Stryker Endoscopy-san Jose.
[80377419]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80377420]
It was reported that the monitor fell on the nurse during room set up before patient arrival
Patient Sequence No: 1, Text Type: D, B5
[109974927]
The device manufacture date is not known. Alleged failure: incident today where a wise 26" monitor display (s/n (b)(4) fell from a tower onto the circulating nurse as she was adjusting it. The tower and monitor were put back into use directly after for cases the arm to be sent in and evaluated to be sure this does not happen again s/n (b)(4). The failure(s) identified in the investigation is consistent with the complaint record. The probable root cause/s could be (1) keyed washer was not used in mounting the monitor (2) the keyed washer getting loose overtime the product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[109974928]
It was reported that the monitor fell on the nurse during room set up before patient arrival.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2017-00692 |
| MDR Report Key | 6723964 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-07-18 |
| Date of Report | 2018-01-04 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-06-29 |
| Date Added to Maude | 2017-07-18 |
| 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. VALERIE ESTRADA |
| 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 | PKG., STRYKERVISION MOUNT |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2017-07-18 |
| Returned To Mfg | 2017-08-30 |
| Catalog Number | 0240095200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-07-18 |