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

Catalog Number 5700000000

Device Problems Break (1069); Scratched Material (3020)

Patient Problem Electric Shock (2554)

Event Date 05/04/2016

Event Type  Injury  

Event Description

It was reported that the customer alleged that the power cord was getting stuck between the litter frame and patient right siderail.The power cord was reported to be damaged with exposed wiring and allegedly caused a patient to be shocked.The severity of the reported shock was not reported.

Manufacturer Narrative

Supplemental submitted to report that the investigation found that there was no patient/user injury alleged related to this event.Additionally, upon further evaluation, it appeared that the power cord was damaged from either the tension of getting caught in the siderail and it being moved, or from being placed under the fowler when it was lowered.The power cord was replaced, and proper routing of the cord was discussed with the customer.

Event Description

It was reported that the customer alleged that the power cord was getting stuck between the litter frame and patient right siderail.The power cord was reported to be damaged with exposed wiring.

• Brand Name: SPIRIT SELECT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1 R6; CA N6E 1R6
• Manufacturer (Section G): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1 R6; CA N6E 1R6
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5692907
• MDR Text Key: 46362109
• Report Number: 3006433555-2016-00136
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

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: No Information
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• 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