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

Catalog Number 8400

Device Problems Crack (1135); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Information was received indicating that a smiths medical pump was returned for analysis.Visual inspection confirmed that the battery compartment was cracked and the battery door was missing.The battery compartment was taken out and glued back together.The split battery compartment was caused by impact caused by the customer.

Event Description

Information was received indicating that a smiths medical capnograph needed to be repaired because the battery compartment is split.There were no reported adverse events.

• Brand Name: CAPNOCHECK II HANDHELD CAPNOGRAPH/OXIMETER
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9295644
• MDR Text Key: 165607513
• Report Number: 3012307300-2019-06131
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• 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