FISHER MARATHON 21K 04-977-21K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-22 for FISHER MARATHON 21K 04-977-21K manufactured by Hermle.

Event Text Entries

[15612198] Users set up centrifuge and received electrical shock upon starting unit. Neither user was injured nor required or received medical attention. Fisher instrument service division personnel serviced unit upon notification of problem. Unit had a defective line filter. Unit repaired. Replacement filter ordered and is to be installed when received. See attached for investigation/follow-up, resultsinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other. Results of evaluation: electrical problem - open circuit. Conclusion: device failed just prior to use. Certainty of device as cause of or contributor to event: yes. Corrective actions: inserviced by manufacturer/distributor representative. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 32606-1992-00001
• MDR Report Key: 914
• Date Received: 1992-07-22
• Date of Report: 1992-07-02
• Report Date: 1992-07-02
• Date Reported to FDA: 1992-07-02
• Date Reported to Mfgr: 1992-06-23
• Date Added to Maude: 1992-07-28
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FISHER MARATHON
• Generic Name: CENTRIFUGE
• Product Code: KSN
• Date Received: 1992-07-22
• Model Number: 21K
• Catalog Number: 04-977-21K
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 871
• Manufacturer: HERMLE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-22