MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-12 for PKG; STANDARD CART W/ ISOLATION TRANSFORMER 0240099011 manufactured by Stryker Endoscopy-san Jose.
[138576880]
The product was not returned for investigation therefore the reported failure mode was not confirmed. Alleged failure: during a power surge the sdc# shut off and took several minutes to come back up. Probable root cause: isolation transformer malfunctions, power strip malfunctions, circuit overload, current inrush, use error. The failure mode will be monitored for future reoccurrence. The device manufacturer date is not known.
Patient Sequence No: 1, Text Type: N, H10
[138576881]
It was reported that the product shut down during a power surge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2019-00098 |
| MDR Report Key | 8413461 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-12 |
| Date Added to Maude | 2019-03-12 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHELLE TO |
| 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; STANDARD CART W/ ISOLATION TRANSFORMER |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2019-03-12 |
| Catalog Number | 0240099011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-12 |