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

Catalog Number 5700000000

Device Problem Malposition of Device (2616)

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

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

Distributor performed evaluation and repair.

Event Description

It was reported by the distributor that the siderail was off its track, possibly resulting a false latch situation.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: SPIRIT SELECT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS (MDR); 1020 adelaide st. s.; N6E1R ; CA N6E1R
• Manufacturer (Section G): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS (MDR); 1020 adelaide st. s.; N6E1R ; CA N6E1R
• Manufacturer Contact: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5123228
• MDR Text Key: 27672884
• Report Number: 3006433555-2015-00398
• 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: distributor
• Reporter Occupation: Other
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: No
• 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