MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-05 for HEMOSAFE 83038-00 manufactured by Angelantoni Life Science Srl.
[3759368]
Hemosafe machine starting capacitor and wiring burnt next to compressor causing overall loss of power.
Patient Sequence No: 1, Text Type: D, B5
[11005415]
(b)(6) hospital experienced a loss of power leading to the notification of the puget sound blood center field service engineer (b)(6). On arrival the engineer discovered various burnt parts and melted wires. No fire alarms were sounded as a result of the burning parts, however the potential for starting a fire still exists. Parts were removed from one the unused puget sound hemosafes to replace the starting components affected by the incident. All melted wires were removed as well. Upon servicing, the compressor was functioning normally for 14 hrs with the exception of a momentary spike in amperage measuring 19-20 amps. Since the parts were replaced, there are no problems starting the unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000631067-2013-00001 |
| MDR Report Key | 3289583 |
| Report Source | 06 |
| Date Received | 2013-08-05 |
| Date of Report | 2013-07-17 |
| Date of Event | 2013-07-17 |
| Date Mfgr Received | 2013-07-24 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2013-10-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MAURIZIO FRANCO |
| Manufacturer Street | LOC. CIMACOLLE, 464 |
| Manufacturer City | MASSA MARTANA PG 06056 |
| Manufacturer Country | IT |
| Manufacturer Postal | 06056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOSAFE |
| Generic Name | NONE |
| Product Code | KSE |
| Date Received | 2013-08-05 |
| Catalog Number | 83038-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGELANTONI LIFE SCIENCE SRL |
| Manufacturer Address | MASSA MARTANA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-05 |