MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500

Catalog Number 10697306

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

The customer provided photos of the power supply.Visual examination of the pictures show signs of damage (bulging/cracking), however inspection of the internal components is not possible, as the power supply is not available for return.The customer has been provided with a replacement power supply and is operational.The cause of this event is unknown.

Event Description

The customer reported that their instrument was making strange noises and they saw smoke coming from the power supply.The instrument was immediately turned off.There was no report of injury due to this event.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10302318
• MDR Text Key: 199690069
• Report Number: 3002637618-2020-00036
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1