MalfunctionLRG

DXM 1040 MICROSCAN WA INSTRUMENT

Received Jun 2, 2020 · Event occurred May 19, 2020

Report 2919016-2020-00001 · MDR key 10111548

Device

Generic name

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Manufacturer

Beckman Coulter

Model number

DXM 1040 MICROSCAN WA INSTRUMENT

Catalog number

B1018-440

Product problems

Device Misassembled During Manufacturing /Shipping
Device Misassembled During Manufacturing /Shipping

Patient

Not reported

No Consequences Or Impact To Patient
No Patient Involvement
Not Applicable
No Consequences Or Impact To Patient
No Patient Involvement
Not Applicable

Narrative

Additional Manufacturer Narrative

BECKMAN COULTER FIELD SERVICE ENGINEER IDENTIFIED THE FAILURE MODE TO BE THAT THE INSTRUMENT SHIPPED WITHOUT RETAINING RING (SHAFT LOCK CLIP) WHICH SECURES THE VERTICAL AXIS (VA) ROD. AS A RESULT, THE COUNTERWEIGHT, COUNTER WEIGHT ROD AND VERTICAL AXIS READ ASSEMBLY SLIPPED CAUSING A NEAR INJURY TO THE FIELD SERVICE ENGINEER (FSE). THE FSE WAS NOT INJURED AS THE PACKAGING MATERIAL CAUGHT THE COUNTERWEIGHT AFTER ONLY 1-INCH SLIP. THE FSE INSTALLED THE RETAINING RING TO RESOLVE THE ISSUE. THE FSE VERIFIED THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ALSO, FSE PERFORMED TOTAL SYSTEM CHECK-OUT AND PERFORMED QUALITY CONTROL (QC) DIAGNOSTICS IN CUSTOMER MODE. INFORMATION NOT PROVIDED. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

Description of Event or Problem

BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPORTED THAT DURING THE UNPACKING OF THE DXM 1040 WALKAWAY INSTRUMENT, THE COUNTERWEIGHT, COUNTER WEIGHT ROD AND VERTICAL AXIS READ ASSEMBLY SLIPPED CAUSING A NEAR INJURY TO THE FSE DUE TO A MISSING SHAFT LOCK CLIP. THE FSE WAS NOT INJURED AS THE PACKAGING MATERIAL CAUGHT THE COUNTERWEIGHT AFTER ONLY 1-INCH SLIP.