MAUDE Adverse Event Report: CAMTEC RC1000 BED; BARIATRIC PATIENT BED

Model Number RC1000ULTRA

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/02/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, "patient was on a bariatric rental bed.He needed to be intubated emergently.The head board on the bed would not come off of the bed.There was a trapeze on the bed.I dont know whether or not the trapeze attachment had anything to do with the headboard getting stuck.Patient had to be turned perpendicular in the bed, with his head and neck hanging off the side, to even attempt intubation.The patient suffered a cardiopulmonary arrest during intubation attempts.There was rosc achieved, but there was a time of no oxygen delivery." complaint# (b)(4) and ra# (b)(4) were entered into our system to have the bed returned to joerns for investigation.As of this writing, the bed has not been returned.

• Brand Name: RC1000 BED
• Type of Device: BARIATRIC PATIENT BED
• Manufacturer (Section D): CAMTEC; 1959 church creek rd; cambridge MD 21613
• Manufacturer (Section G): CAMTEC; 1959 church creek rd; cambridge MD 21613
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 9097929
• MDR Text Key: 159355734
• Report Number: 3009402404-2019-00061
• Device Sequence Number: 1
• Product Code: OSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RC1000ULTRA
• Device Catalogue Number: RC1000ULTRA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/12/2019
• 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
• Patient Outcome(s): Death