MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. BCI CAPNOCHECK II CAPNOGRAPH; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 8400

Device Problems Crack (1135); Battery Problem (2885); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

One capnography monitor was returned for analysis in bad condition.Upon visual inspection it was found that the battery compartment was cracked open.A battery was inserted, and unit did not power up.The battery compartment was observed to have been glued back together several times.The top of the pump was found that it had come off completely upon internal visual inspection.The main board was replaced, and the unit then powered up.However, the left side of the display was missing.Based on the evidence, the complaint was confirmed.The root cause was found to be user interface as the unit appeared to be severely damaged from a drop.

Event Description

Information was received indicating that a smiths medical bci® capnocheck® ii capnograph would not turn on.New batteries were placed with still no power.It was reported that this fault did not occur during patient use.There were no reported adverse effects.

• Brand Name: BCI CAPNOCHECK II CAPNOGRAPH
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 9521891
• MDR Text Key: 177563370
• Report Number: 3012307300-2019-07466
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8400
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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