MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA DRÄGERSORB 800 PLUS (5L); ABSORBENT, CARBON-DIOXIDE

Catalog Number MX00001

Device Problem Mechanical Jam (2983)

Patient Problems Muscular Rigidity (1968); Hypoesthesia, Arm/Hand (2353)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that during a case the fraction of expired co2 increased so that replacement of the lime in the bin was necessary.The nurse reportedly was not able to open the new bin.While trying she hurt her right hand and right arm.After the event we were informed that the nurse suffered from searing pain in the thumb and right arm.Additionally it resulted in permanent musculo-tendon pain, an inability to perform some gestures involving hand, wrist and right forearm.

• Brand Name: DRÄGERSORB 800 PLUS (5L)
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9817334
• MDR Text Key: 182909770
• Report Number: 9611500-2020-00070
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX00001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other