MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX SP90

Model Number	944-157
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A medical worker touched the leaked liquid that may contain blood.She wore gloves.
Additional Manufacturer Narrative
The solution pack has been investigated, and it has been concluded that the defect is due to assembly error, and that this is not a systematic error.

• Brand Name: ABL90 FLEX SP90
• Common Device Name: ABL90 FLEX SP90
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 6727373
• Report Number: 3002807968-2017-00022
• Device Sequence Number: 855900
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: 05700699441577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2017
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: YI20
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1