MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-02-21 for CENTRIFUGE 115V 50/60HZ DRUCKR 755VES manufactured by Zimmer Biomet, Inc..
[136766907]
(b)(4). Multiple mdrs were filed for this event. Please see associated: 0001825034 - 2019 - 00763. The device has been returned and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136766908]
It was reported the centrifuge malfunctioned causing the balancing to be off, not allowing for an accurate spin. This was identified in an office setting; no patient or surgical involvement. No further information is available at the time of this reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-00771 |
| MDR Report Key | 8357746 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-02-21 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-02-21 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRIFUGE 115V 50/60HZ DRUCKR |
| Generic Name | BLOOD WORK SUPPLIES |
| Product Code | KSS |
| Date Received | 2019-02-21 |
| Returned To Mfg | 2019-02-20 |
| Catalog Number | 755VES |
| Lot Number | 150660AA113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 755 | 2019-02-21 |