MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX SP90

Model Number 944-157

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2017

Event Type  malfunction  

Event Description

A medical worker touched the leaked liquid that may contain blood.She wore gloves.

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
• Type of Device: ABL90 FLEX SP90
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: david kawiecki ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 6727373
• MDR Text Key: 80518240
• Report Number: 3002807968-2017-00022
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: 05700699441577
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1