MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO DOMESTIC APP CONTROL UNIT

Catalog Number C1000D

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2015

Event Type  Injury  

Manufacturer Narrative

The unit was not made available in order to perform an evaluation and no information was provided pertaining to the alleged adverse event.A follow-up will be submitted if additional information becomes available.

Event Description

It was reported that the unit allegedly caught on fire and there were adverse consequences, however, no additional information has been provided.

• Brand Name: DOMESTIC APP CONTROL UNIT
• Type of Device: CONTROL UNIT
• 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: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5151245
• MDR Text Key: 28308237
• Report Number: 0001831750-2015-00491
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: C1000D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2015
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1