MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-17 for REPLACEMENT POWER CORD FOR TEKNA CARTS 0240099069 manufactured by Stryker Endoscopy-san Jose.
[57696489]
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
[57696490]
It was reported that smoke triggered out of the outlet area where the tower was plugged, resulting in a small fire. They were able to unplug the tower and take care of the fire. No adverse consequences or patient involvement in the event
Patient Sequence No: 1, Text Type: D, B5
[70486528]
The product was not returned for investigation therefore the reported failure mode was not confirmed. Alleged failure: smoke started coming out of the outlet area where the tower was plugged probable root cause: too much heat, transformer design, cart design , manufacturing nonconformity, use error. The failure mode will be monitored for future reoccurrence. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70486529]
It was reported that smoke triggered out of the outlet area where the tower was plugged, resulting in a small fire. They were able to unplug the tower and take care of the fire. No adverse consequences or patient involvement in the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-00970 |
| MDR Report Key | 6035456 |
| Date Received | 2016-10-17 |
| Date of Report | 2017-03-21 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2016-09-20 |
| Date Added to Maude | 2016-10-17 |
| 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 | REPLACEMENT POWER CORD FOR TEKNA CARTS |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2016-10-17 |
| Catalog Number | 0240099069 |
| Lot Number | UNK |
| 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 | 2016-10-17 |