MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE OMNI S; BLOOD GAS ANALYZER

Catalog Number 03337154001

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that the printer of the cobas b 221 analyzer was overheating.The analyzer did not generate any errors.The analyzer was switched off and the printer was taken out.The reporter noted the printer was hot to the touch and when trying to replace the paper, the paper was marked black as if was burned.There was no other evidence of smoke, fire, or melting.

Manufacturer Narrative

The printer from the analyzer was returned for investigation.The printer had no visible defects.After installing the printer, a report was printed.The left side of the printout was not readable and had continuous black stripes in the middle and nothing was printed.On the right side of the printout, everything was printed correctly and readable.Roughly one week after the last printout had been printed, it was observed that the printing paper was discolored with a horizontal black stain.The stain was bigger on the left side than on the right side.The printer works with a method of thermal printing.This process produces the printout by selectively heating the coated thermochromic paper.It is likely that the control of the thermal head was defective, causing a black stain only on the left side of the paper, after the paper remained in the same position for one week.Upon review of the instrument database, it showed a system stop error (power failure) on 10-jul-2020 at 10:04.The instrument was restarted on 13-jul-2020.This suggests that the instrument was shut down immediately without following the workflow.Apart from that, nothing suspicious was seen in the databases.Based on internal testing of the cobas b221 instruments, the equipment was tested for use at the maximum ambient temperature permitted by the manufacturer´s specification of: 32 °c.The customer confirmed that the temperature was lower than 32 °c.In order to pass these tests, the device is designed from the very beginning to avoid a possible fire.The board material must have the fire protection class 94v-0.These components must be tested by ul or csa, may not be modified and can only be purchased from the listed approved manufacturers.There is no risk of the printer or the printing paper catching fire.It has been confirmed that the issue has never occurred during production.The investigation could not identify a product problem.The cause of the printer malfunction could not be determined.The issue was resolved by replacement of the printer.

• Brand Name: ROCHE OMNI S
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10361340
• MDR Text Key: 201576090
• Report Number: 1823260-2020-01881
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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 Catalogue Number: 03337154001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1