MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV COLDER CON; SYSTEM, THERMAL REGULATING

Model Number	8001-061-610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the altrix machine was running, the altrix blanket burst with water while attached to the patient.It was reported that the patient had a preexisting grade 3 pressure sore with a newly dressed wound.Due to bursting of the blanket, the dressing became soiled and the wound was wet.The procedure was not completed and the wound needed to be redressed using an aseptic technique.No injury was reported as result of this event.
Event or Problem Description
It was reported that while the altrix machine was running, the altrix blanket burst with water while attached to the patient.It was reported that the patient had a preexisting grade 3 pressure sore with a newly dressed wound.Due to bursting of the blanket, the dressing became soiled and the wound was wet.The procedure was not completed and the wound needed to be redressed using an aseptic technique.No injury was reported as result of this event.
Additional Manufacturer Narrative
Corrected reportability awareness date in section g3.
Additional Manufacturer Narrative
The customer was not able to confirm where the burst occurred or for how long the blanket was in use before the incident occurred.The customer also did not have photos of the blanket available as it was discarded.H3 other text: device was discarded.
Event or Problem Description
It was reported that while the altrix machine was running, the altrix blanket burst with water while attached to the patient.It was reported that the patient had a preexisting grade 3 pressure sore with a newly dressed wound.Due to bursting of the blanket, the dressing became soiled and the wound was wet.The procedure was not completed and the wound needed to be redressed using an aseptic technique.No injury was reported as result of this event.

• Brand Name: BLKT 1-SIDE NONWOV COLDER CON
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16898792
• Report Number: 0001831750-2023-00644
• Device Sequence Number: 20198392
• Product Code: DWJ
• UDI-Device Identifier: 07613327175127
• UDI-Public: 07613327175127
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K100585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2023

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
• Device Model Number: 8001-061-610
• Device Catalogue Number: 8001061610
• Device Lot Number: 303946
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 04/20/2023; 04/20/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/17/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male