MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LD304 MATERNITY BED; TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

Catalog Number 4701000000

Device Problems Break (1069); Component Missing (2306); Material Integrity Problem (2978)

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

Event Date 12/10/2013

Event Type  malfunction  

Event Description

It was reported via repair work order that the headend litter plastic cover and headboard were damaged with sharp edges.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was initially reported that the calf support/abduction was missing and the headboard was damaged with sharp edges.Follow-up submitted as further investigation determined the calf support/abduction was not missing and the headend litter plastic cover was also damaged with sharp edges.

Event Description

It was reported via repair work order that the calf support/abduction was missing.It was further reported that the headboard was damaged with sharp edges.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: LD304 MATERNITY BED
• Type of Device: TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3556046
• MDR Text Key: 18568710
• Report Number: 0001831750-2014-00213
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950889
• 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: 12/10/2013

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 Operator: Other
• Device Catalogue Number: 4701000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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