MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER; TEMPERATURE MANAGEMENT CONVECTIVE WARMER

Model Number L1-CW-120V

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problems Chills (2191); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.

Event Description

It was reported that the new convective warmers are taking longer to warm patients compared to previous product.Units take at least 2-hours longer to warm patients.It was suggested adding a cotton sheet on top of the warming blanket.Staff tried this and there was no change/impact.This is reported to have lead to extended patient discomfort, longer wait-times, significantly decreased pacu's throughput, and may cause some surgeries to be cancelled due to delayed warming times.No report of patient death or serious injury.

Manufacturer Narrative

Manufacturing device history record review was not performed because manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.Should the product be returned or additional information be returned pertinent to the investigation, a supplemental report will be filed.

Event Description

Adverse event.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.E4 is unknown.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Type of Device: TEMPERATURE MANAGEMENT CONVECTIVE WARMER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14593777
• MDR Text Key: 293285517
• Report Number: 3012307300-2022-10625
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 15019517121551
• UDI-Public: 15019517121551
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L1-CW-120V
• Device Catalogue Number: L1-CW-120V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization