MAUDE Adverse Event Report: STRYKER MEDICAL SPIRIT SELECT; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5700

Device Problems Thermal Decomposition of Device (1071); Material Frayed (1262); Sparking (2595)

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

Event Date 11/26/2017

Event Type  malfunction  

Event Description

Patient was in a hospital bed when the cord popped.There were visible sparks and there are burn marks on the bed.The cord is stripped and frayed and the bare copper wire is exposed.

• Brand Name: SPIRIT SELECT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 7167213
• MDR Text Key: 96463597
• Report Number: 7167213
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5700
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR