MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-11 for SYNCARDIA FREEDOM HOME AC POWER SUPPLY 295600-001 manufactured by Syncardia Systems, Llc.
[178797374]
The freedom home ac power supply will be returned to syncardia for evaluation. The results of the investigation will be provided in a follow-up mdr. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178797375]
The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source. The customer, a syncardia authorized distributor, reported that when the patient's freedom home ac power supply was plugged into the freedom driver, the freedom driver exhibited an alarm and stopped alarming when the freedom driver was moved slightly. The customer also reported that there was no adverse patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00063 |
| MDR Report Key | 9693337 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2020-02-11 |
| 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 | MS. KERRI HENSLEY |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON, AZ AZ 85713 |
| Manufacturer Country | US |
| Manufacturer Postal | 85713 |
| Manufacturer Phone | 5205451234 |
| Manufacturer G1 | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON AZ 85713 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85713 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCARDIA FREEDOM HOME AC POWER SUPPLY |
| Generic Name | AC POWER SUPPLY |
| Product Code | LOZ |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-02-05 |
| Catalog Number | 295600-001 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Address | 1992 E. SILVERLAKE ROAD TUCSON, AZ AZ 85713 US 85713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |