MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-05 for SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK 293001-001 manufactured by Syncardia Systems, Llc.
[177993039]
The companion external battery has been 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
[177993040]
The reported issue is reported under two separate medical device reports: (1) companion external battery s/n (b)(4) and (2) companion external battery s/n (b)(4) (mfr report # 3003761017-2020-00064). The customer, a syncardia certified hospital, reported that the companion external batteries drained from full charge to emergency battery within 10 minutes during transport of the patient. The batteries were recharged and then drained again during transport. The companion 2 emergency (internal) battery worked as intended and there was no adverse impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00040 |
| MDR Report Key | 9673217 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2020-02-05 |
| 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. KERRI HENSLEY |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON AZ 85713 |
| Manufacturer Country | US |
| Manufacturer Postal | 85713 |
| Manufacturer Phone | 5205451234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK |
| Generic Name | BATTERY PACK |
| Product Code | LOZ |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-01-21 |
| Catalog Number | 293001-001 |
| Device Expiration Date | 2020-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Address | 1992 E. SILVERLAKE ROAD TUCSON AZ 85713 US 85713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |