MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® SNUGGLE WARM® BLANKETS; SYSTEM, THERMAL REGULATING

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that during patient use of the snuggle warm® blanket the patient experienced burns and erythema on the left arm.According to the report, the blanket was in use with an equator® convective warming device and the warming device continued to warm "while the temperature had reached 45° celsius".The reported redness on the patient was observed after an "intervention" that lasted one hour and thirty minutes.The patient received an application of biafine cream on the redness and the site was monitored for twenty-four hours; no redness was observed after.The programed temperature of the warming device has been requested; however, it is currently unknown.No permanent damage was reported.Related mfr #'s: 3012307300-2017-00957 and 3012307300-2017-00958.

Manufacturer Narrative

Smiths medical received one snuggle warm® blanket for analysis in a used condition.Upon visual examination two holes were noted to the middle section of the blanket.Quality inspections were performed in 2 hour intervals, burst tests, 4 hour performance tests and internal pressure tests were completed.Relevant documents were reviewed and deemed adequate.The samples were acceptable with no discrepancies noted.Manufacturing process was conducted to verify that there were no non-conformances.A review of the instructions for use (ifu) was performed; warnings were noted upon review that the blanket is just the air distribution device and the connective warmer generates the heat.Functional testing was performed on a sample that was taken from production and connected to an equator.The sample demonstrated good performance.No root cause was found due to the complaint not being confirmed.

• Brand Name: LEVEL 1® SNUGGLE WARM® BLANKETS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6523374
• MDR Text Key: 73751352
• Report Number: 3012307300-2017-00914
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention