MAUDE Adverse Event Report: ORIDION MEDICAL ORIDION MEDICAL; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	CS08657-02
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the unit did not generate an audible alarm.It was reported that there was no patient involvement.
Additional Manufacturer Narrative
One sample was received for analysis and the reported issue was confirmed.Customer speaker was removed and reconnected.Audio was found to be intermittent based on the position of the white speaker wire connection at the speaker side.Visual inspection under magnification found a cracked solder joint.Speaker was removed and retained.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the unit did not generate an audible alarm.It was reported that there was no patient involvement.

• Brand Name: ORIDION MEDICAL
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• MDR Report Key: 6997677
• Report Number: 8044004-2017-05009
• Device Sequence Number: 16466835
• Product Code: CCK
• UDI-Device Identifier: 10884521551503
• UDI-Public: 10884521551503
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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 Model Number: CS08657-02
• Device Catalogue Number: CS08657-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1