MAUDE Adverse Event Report: UNKNOWN DIRECT SUPPLY - PANACEA; BED, BARIATRIC, POWER

Model Number	0-99545
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bed.The affected component was the hand control.The device was returned for evaluation.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The certified nursing assistant was adjusting the bed for the patient when it reportedly exploded.The cna was taken to the er where he was diagnosed with a ruptured ear drum.The control box was sent back for evaluation.The unit was moderately used.The case arrived in broken pieces.The control box may have broken due to an applied force on it from another object.One wire in the control box was detached.There was no sign of electronics exploding.There were no unusual smells.A root cause cannot be determined at this time.Historical data for complaint of the same nature was reviewed showing no trends.This is considered an isolated incident.

• Brand Name: DIRECT SUPPLY - PANACEA
• Common Device Name: BED, BARIATRIC, POWER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11301749
• Report Number: 2438477-2018-00096
• Device Sequence Number: 4959454
• Product Code: OSI
• UDI-Device Identifier: 00822383549804
• UDI-Public: 822383549804
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2021
• Report Date (Section F): 02/09/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 0-99545
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/17/2018
• Device Age: 5 YR
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 22 YR
• Patient Weight: 48
• Date Report Sent to FDA: 02/09/2021