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

Model Number MODEL 100

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

It was reported that during a device check by the customer, the encoder shaft of the autopulse platform was too tight to rotate.Zoll (b)(4) confirmed the reported event and found that the encoder shaft did not rotate at all.The platform also displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/28/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection was performed and the load plate cover was found to be damaged.After powering on the device for initial functional testing, the platform displayed a constant user advisory (ua) 45 (not at "home" position after power-on/ restart).Evaluation of the platform identified that this was caused by the encoder shaft being one revolution off from the "home" position target upon power on of the device.The reported complaint of difficulty in rotating the encoder shaft was also observed during internal inspection of the platform, thus confirming the reported complaint.Further inspection found that the difficulty in rotating the encoder shaft was due to burrs in the clutch plate on the hex cut out as well as on the surface of the clutch rotor.Both sides of the clutch plate were de-burred and the encoder shaft was set back to its "home" position in order to remedy the complaint.Following this service, the encoder assembly shaft was found to spin freely with no friction.The platform was then functionally tested with no further user advisories observed.The platform's archive was reviewed and multiple ua 45 codes were seen to have occurred on the reported event date of (b)(6) 2015.The cause of the ua 45 codes was previously identified as the encoder shaft being one revolution off from the "home" position.Based on the investigation, the part identified for replacement was the damaged load plate cover.In summary, the reported complaint of difficulty rotating the encoder shaft was confirmed during functional testing and attributed to burrs in the clutch plate on the hex cut out as well as on the surface of the clutch rotor.After de-burring the clutch plate, this issue was resolved.The platform displaying ua 45, as confirmed by zoll (b)(4) on the initial report, was also verified upon functional testing and platform archive review.The ua 45 codes were attributed to the previously identified observation of the encoder shaft being one revolution out of its "home" position.Following service, including de-burring of the clutch plate and resetting the encoder shaft back to its "home" position, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4517786
• MDR Text Key: 5487723
• Report Number: 3010617000-2015-00099
• 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,Followup
• Report Date: 01/21/2015

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: 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: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 02/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2010
• 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