MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Material Too Rigid or Stiff (1544); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2013

Event Type  malfunction  

Event Description

Complainant alleged that during a shift check, the autopulse resuscitation system displayed a user advisory ua45 (not at "home" position after power-on/restart) message, when the autopulse lifeband was installed.Customer attempted to reinstall the lifeband; however, the user advisory was unable to be cleared.Once the driveshaft was adjusted through the administrator menu, the user advisory message resolved.Customer also reported that the driveshaft was rigid and therefore unable to rotate properly.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Zoll (b)(4) was unable to duplicate the user advisory ua 45 message; however, the report of the driveshaft being too rigid was confirmed.The autopulse platform (s/n (b)(4)) was returned for evaluation.The reported complaint of the platform displaying a user advisory 45 fault (not at home position after power-on/re-start) was confirmed.The autopulse resuscitation system model 100 user guide (p/n 12555-001) states: "the autopulse driveshaft has a home position that is a point of reference for autopulse operation.If the driveshaft is not at its "home" position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position".The autopulse user guide also states: "removing the band clip when the driveshaft is not at its home position will result in a permanent user advisory (45) that the user will not be able to clear.The lifeband should be removed from the driveshaft only from its home position".A review of the archive does not show the fault occurring on the reported event date of (b)(6) 2013; however multiple ua 45 faults were found in the archive including an occurrence on (b)(6) 2013.During inspection of the platform, the cause was found to be that the encoder shaft was sticking due to the edges of the clutch plate being damaged, thereby preventing the shaft from spinning freely.Following service of the platform, including replacement of the damaged clutch plate, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3598257
• MDR Text Key: 4188205
• Report Number: 3003793491-2014-00052
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2011
• 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