MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-22 for SAMSUNG SAMSUNG TAB E SM-T377A manufactured by Visicu, Inc - Dup.
[180760295]
Investigation and objective evidence revealed no burning, melting or charring of the adaptor or cord. The adaptor was identified as an unapproved/supported/supplied adaptor used by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[180760296]
It was reported on (b)(6) 2019 that the cord to the tablet was on fire. Nurse asked patient if there were active sparks or fire. Patient reported she was unsure. Nurse confirmed there was no injury to the patient. Installer returned to the patient home on (b)(6) 2020 to retrieve the cord and tablet and subsequently returned the entire kit including the ecad bp, spo2, and the scale which is the entire kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125873-2020-00001 |
| MDR Report Key | 9617491 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-02 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON FISHTER |
| Manufacturer Street | 217 E REDWOOD ST STE 1900 |
| Manufacturer City | BALTIMORE MD 21202 |
| Manufacturer Country | US |
| Manufacturer Postal | 21202 |
| Manufacturer G1 | PHILIPS HEALTHCARE (ALPHARETTA) |
| Manufacturer Street | ONE DEERFIELD CENTER 13560 MORRIS ROAD STE 2100 |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAMSUNG |
| Generic Name | N/A |
| Product Code | MSX |
| Date Received | 2020-01-22 |
| Model Number | SAMSUNG TAB E SM-T377A |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISICU, INC - DUP |
| Manufacturer Address | 217 E REDWOOD ST STE 1900 BALTIMORE MD 21202 US 21202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-22 |