MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION 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 06/03/2015

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform constantly displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message and the lifeband is very stiff and difficult to extend.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform ((b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and the top cover and motor cover were observed to be damaged.It was also observed that the head restraint brackets were cracked and the battery partition cover was missing.From the condition of the platform, the damages appear to have been due to wear and tear.Functional testing was performed and it was observed that the drive shaft was unable to rotate freely.The customer's reported complaint of the lifeband being stiff and difficult to extend was observed during testing and is attributed to the clutch plate being sticky.The sticky clutch plate could lead to the drive shaft not being in the "home" position, which in turn could result in the platform displaying a user advisory (45).However, the user advisory (ua) 45 was unable to be duplicated during functional evaluation.A review of the archive was performed and no user advisories or errors were observed on the reported event date of (b)(6) 2015.However, multiple user advisory 45 errors were observed on (b)(6) 2015, which was the last date of usage recorded in the archive.Based on the investigation, the part(s) identified for replacement are the top cover, motor cover, clutch plate and battery partition cover.In summary, the reported complaint of the platform displaying a ua 45 and the lifeband being difficult to extend was confirmed through functional testing and archive review and is attributed to the clutch plate being sticky.Following service, 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: 4870078
• MDR Text Key: 20147436
• Report Number: 3010617000-2015-00362
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/03/2015

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2007
• 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