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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

It was initially reported that two screws on the back of the autopulse dislodged and may be inside the unit.A rubber ring was also observed to be dislodged.No patient involvement was reported.The autopulse platform was subsequently returned to zoll for investigation.During investigation, a user advisory (ua) 18 (max take-up revolutions exceeded) message was observed in the archive on the reported event date.Although the customer did not report this, ua 18 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.The reported complaint was confirmed: visual inspection was performed and the encoder cover was found to be damaged as well as the rubber grip strip being dislodged.Additional damages were observed on the head restraint brackets, the patient restraint pin assembly, and the load plate cover.From the condition of the returned unit, the damages appear to have been due to wear and tear.The platform was tested for 10 minutes with a test mannequin and an additional 15 minutes with a lrtf (large resuscitation test fixture) and no problems were encountered.Unrelated to the reported complaint, a user advisory 18 (max take-up revolutions exceeded) was observed in the archive.The reported information as well as the archive data does not indicate that the platform was used on a patient or object at the time this advisory was exhibited.There were also no anomalies observed with the platform during physical evaluation which could have caused or contributed to the observed user advisory.It should be noted that a ua 18 is considered a normal advisory when the user is storing the lifeband in the ready position.Based on the investigation, the parts identified for replacement were the encoder cover, patient restraint assembly, patient pin assembly, and load plate cover.In summary, the reported complaint was confirmed during visual inspection and was attributed to wear and tear.Unrelated to the reported complaint, a user advisory 18 (max take-up revolutions exceeded) was observed in the archive.Based on the investigation, the ua 18 was exhibited due to the user storing the lifeband in the ready position.Following service, including replacement of the damaged parts, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4169848
• MDR Text Key: 16855781
• Report Number: 3010617000-2014-00526
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2006
• 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